[USC02] 21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 3: fees relating to devices
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21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 3: fees relating to devices
From Title 21—FOOD AND DRUGSCHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER VII—GENERAL AUTHORITYPart C—Fees

subpart 3—fees relating to devices

§379i. Definitions

For purposes of this subpart:

(1) The term "premarket application" means—

(A) an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or

(B) a product development protocol described in section 360e(f) of this title.


Such term does not include a supplement, a premarket report, or a premarket notification submission.

(2) The term "premarket report" means a report submitted under section 360e(c)(2) of this title.

(3) The term "premarket notification submission" means a report submitted under section 360(k) of this title.

(4)(A) The term "supplement", with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which—

(i) an application or report has been approved under section 360e(d) of this title, or an application has been approved under section 262 of title 42; or

(ii) a notice of completion has become effective under section 360e(f) of this title.


(B) The term "panel-track supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.

(C) The term "180-day supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.

(D) The term "real-time supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.

(E) The term "efficacy supplement" means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.

(5) The term "30-day notice" means a notice under section 360e(d)(5) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.

(6) The term "request for classification information" means a request made under section 360c(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device.

(7) The term "annual fee", for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.

(8) The term "de novo classification request" means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device.

(9) The term "process for the review of device applications" means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, and premarket notification submissions:

(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.

(B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.

(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary's review of pending premarket applications, premarket reports, and supplements.

(D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, and submissions.

(E) Review of device applications subject to section 262 of title 42 for an investigational new drug application under section 355(i) of this title or for an investigational device exemption under section 360j(g) of this title and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title.

(F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.

(G) The development of voluntary test methods, consensus standards, or mandatory performance standards under section 360d of this title in connection with the review of such applications, reports, supplements, or submissions and related activities.

(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, or submissions.

(I) Any activity undertaken under section 360c or 360e(i) of this title in connection with the initial classification or reclassification of a device or under section 360e(b) of this title in connection with any requirement for approval of a device.

(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.

(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, or premarket notification submissions.


(10) The term "costs of resources allocated for the process for the review of device applications" means the expenses in connection with the process for the review of device applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.


(11) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2016.

(12) The term "person" includes an affiliate thereof.

(13) The term "affiliate" means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.


(14) The term "establishment subject to a registration fee" means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.

(June 25, 1938, ch. 675, §737, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108–214, §2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577; Pub. L. 110–85, title II, §211, Sept. 27, 2007, 121 Stat. 843; Pub. L. 112–144, title II, §202, July 9, 2012, 126 Stat. 1002; Pub. L. 114–255, div. A, title III, §3051(c)(2), Dec. 13, 2016, 130 Stat. 1124; Pub. L. 115–52, title II, §202(a), Aug. 18, 2017, 131 Stat. 1013.)

Termination of Section

For termination of section by section 210(a) of Pub. L. 115–52, see Effective and Termination Dates note below.

Amendments

2017—Par. (8). Pub. L. 115–52, §202(a)(2), added par. (8). Former par. (8) redesignated (9).

Par. (9). Pub. L. 115–52, §202(a)(1), redesignated par. (8) as (9). Former par. (9) redesignated (10).

Par. (10). Pub. L. 115–52, §202(a)(1), (3), redesignated par. (9) as (10) and substituted "submissions, and de novo classification requests" for "and submissions" in subpar. (D). Former par. (10) redesignated (11).

Par. (11). Pub. L. 115–52, §202(a)(1), (4), redesignated par. (10) as (11) and substituted "2016" for "2011".

Pars. (12) to (14). Pub. L. 115–52, §202(a)(1), redesignated pars. (11) to (13) as (12) to (14), respectively.

2016—Par. (5). Pub. L. 114–255 substituted "360e(d)(5)" for "360e(d)(6)".

2012—Par. (9). Pub. L. 112–144, §202(1), struck out "incurred" after "expenses" in introductory provisions.

Par. (10). Pub. L. 112–144, §202(2), substituted "October 2011" for "October 2001".

Par. (13). Pub. L. 112–144, §202(3), substituted "is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device." for "is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:" and struck out subpars. (A) to (C) which related to manufacturer, single-use device reprocessor, and specification developer establishments.

2007Pub. L. 110–85, §211(1), substituted "For purposes of this subpart" for "For purposes of this part" in introductory provisions.

Pars. (5) to (9). Pub. L. 110–85, §211(2), (3), added pars. (5) to (7) and redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively.

Par. (10). Pub. L. 110–85, §211(2), (4), redesignated par. (7) as (10) and substituted "October of the preceding fiscal year" for "April of the preceding fiscal year" and "October 2001" for "April 2002".

Par. (11). Pub. L. 110–85, §211(5), added par. (11).

Par. (12). Pub. L. 110–85, §211(2), redesignated par. (8) as (12).

Par. (13). Pub. L. 110–85, §211(6), added par. (13).

2004Pub. L. 108–214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, §102(a), which enacted this section.

Par. (4)(B). Pub. L. 108–214, §2(a)(1)(A), substituted "and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness" for "and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness".

Par. (4)(D). Pub. L. 108–214, §2(a)(1)(B), struck out "manufacturing," after "software,".

Par. (5)(J). Pub. L. 108–214, §2(a)(1)(C), substituted "a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42." for "a premarket application under section 360e of this title or section 262 of title 42."

Par. (8). Pub. L. 108–214, §2(a)(1)(D), substituted "The term 'affiliate' means a business entity that has a relationship with a second business entity (whether domestic or international)" for "The term 'affiliate' means a business entity that has a relationship with a second business entity".

Effective Date of 2017 Amendment

Pub. L. 115–52, title II, §209, Aug. 18, 2017, 131 Stat. 1020, provided that: "The amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective Date of 2012 Amendment

Pub. L. 112–144, title II, §206, July 9, 2012, 126 Stat. 1007, provided that: "The amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] shall take effect on October 1, 2012, or the date of the enactment of this Act [July 9, 2012], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2012, regardless of the date of the enactment of this Act."

Effective and Termination Dates of 2007 Amendment

Pub. L. 110–85, title II, §216, Sept. 27, 2007, 121 Stat. 852, provided that: "The amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title] shall take effect on October 1, 2007, or the date of the enactment of this Act [Sept. 27, 2007], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all premarket applications, premarket reports, supplements, 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the date of the enactment of this Act."

Pub. L. 110–85, title II, §217, Sept. 27, 2007, 121 Stat. 852, which provided that the amendments by sections 211 to 217 of Pub. L. 110–85 (amending this section and section 379j of this title) would cease to be effective Oct. 1, 2012, and that section 379j–1 of this title would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title II, §207(b)(1), July 9, 2012, 126 Stat. 1007.

Effective and Termination Dates

Pub. L. 115–52, title II, §210(a), Aug. 18, 2017, 131 Stat. 1020, provided that: "Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i [379i]; 739j [379j]) shall cease to be effective October 1, 2022."

Pub. L. 112–144, title II, §207(a), July 9, 2012, 126 Stat. 1007, which provided that sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) would cease to be effective Oct. 1, 2017, and that section 738A (21 U.S.C. 379j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title II, §210(c), Aug. 18, 2017, 131 Stat. 1020.

[Pub. L. 115–52, title II, §210(c), Aug. 18, 2017, 131 Stat. 1020, provided that the repeal of section 207(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 107–250, title I, §106, Oct. 26, 2002, 116 Stat. 1602, provided that: "The amendments made by this title [enacting this subpart] shall take effect on the date of the enactment of this Act [Oct. 26, 2002], except that fees shall be assessed for all premarket applications, premarket reports, supplements, and premarket notification submissions received on or after October 1, 2002, regardless of the date of enactment."

Pub. L. 107–250, title I, §107, Oct. 26, 2002, 116 Stat. 1602, which provided that the amendments made by title I of Pub. L. 107–250 (enacting this subpart) would cease to be effective Oct. 1, 2007, except that section 103 of Pub. L. 107–250, set out as a note below, would cease to be effective Jan. 31, 2008, was repealed by Pub. L. 112–144, title II, §207(c)(1), July 9, 2012, 126 Stat. 1007.

[Pub. L. 112–144, title II, §207(c), July 9, 2012, 126 Stat. 1007, provided that the repeal of section 107 of Pub. L. 107–250, formerly set out above, is effective Sept. 30, 2007.]

Savings Provision

Pub. L. 115–52, title II, §208, Aug. 18, 2017, 131 Stat. 1019, provided that: "Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Pub. L. 112–144, title II, §205, July 9, 2012, 126 Stat. 1007, provided that: "Notwithstanding the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (in effect as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013."

Pub. L. 110–85, title II, §214, Sept. 27, 2007, 121 Stat. 852, provided that: "Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) [formerly set out as an Effective and Termination Dates note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle [Sept. 27, 2007], shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008."

Findings

Pub. L. 115–52, title II, §201(b), Aug. 18, 2017, 131 Stat. 1013, provided that: "The Congress finds that the fees authorized under the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title II, §201(b), July 9, 2012, 126 Stat. 1002, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 110–85, title II, §201(c), Sept. 27, 2007, 121 Stat. 842, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379j–1 of this title and amending this section and sections 333, 360, 360i, 360m, 374, and 379j of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 107–250, title I, §101, Oct. 26, 2002, 116 Stat. 1589, provided that: "The Congress finds that—

"(1) prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met; and

"(3) the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and section 379j of this title] will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record."

Annual Reports

Pub. L. 107–250, title I, §103, Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 109–43, §2(b), Aug. 1, 2005, 119 Stat. 441, provided that:

"(a) In General.—Beginning with fiscal year 2003, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report concerning—

"(1) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of Pub. L. 107–250 does not contain parts]; and

"(2) the implementation of the authority for such fees during such fiscal year, and the use, by the Food and Drug Administration, of the fees collected during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102 [enacting this subpart].

"(b) Additional Information.—For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include—

"(1) information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and

"(2) a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) [now (8)] of section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not less than such amounts for fiscal year 2002 multiplied by the adjustment factor, as defined in paragraph (7) [now (10)] of such section 737."

Study

Pub. L. 107–250, title I, §104(b), Oct. 26, 2002, 116 Stat. 1601, directed the Secretary of Health and Human Services to conduct a study for the purpose of making certain determinations regarding the medical device user-fee program established under the amendment made by section 102 of Pub. L. 107–250 and to submit a report to Congress by Jan. 10, 2007.

Consultation

Pub. L. 107–250, title I, §105, Oct. 26, 2002, 116 Stat. 1601, provided that:

"(a) In General.—In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of medical device applications for fiscal years after fiscal year 2007, and for the reauthorization of sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i, 379j], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.

"(b) Recommendations.—The Secretary shall publish in the Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations."

§379j. Authority to assess and use device fees

(a) Types of fees

(1) In general

Beginning in fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section.

(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device

(A) In general

Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2017, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:

(i) A premarket application.

(ii) For a premarket report, a fee equal to the fee that applies under clause (i).

(iii) For a panel track supplement, a fee equal to 75 percent of the fee that applies under clause (i).

(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).

(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).

(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).

(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).

(viii) For a premarket notification submission, a fee equal to 3.4 percent of the fee that applies under clause (i).

(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).

(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).

(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).

(B) Exceptions

(i) Humanitarian device exemption

An application under section 360j(m) of this title is not subject to any fee under subparagraph (A).

(ii) Further manufacturing use

No fee shall be required under subparagraph (A) for the submission of a premarket application under section 262 of title 42 for a product licensed for further manufacturing use only.

(iii) State or Federal Government sponsors

No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, or premarket notification submission submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.

(iv) Premarket notifications by third parties

No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 360m of this title.

(v) Pediatric conditions of use

(I) In general

No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.

(II) Subsequent proposal of adult conditions of use

In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.

(C) Payment

The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.

(D) Refunds

(i) Application refused for filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.

(ii) Application withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.

(iii) Application withdrawn before first action

After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.

(iv) Modular applications withdrawn before first action

The Secretary shall refund 75 percent of the application fee paid for an application submitted under section 360e(c)(4) of this title that is withdrawn before a second portion is submitted and before a first action on the first portion.

(v) Later withdrawn modular applications

If an application submitted under section 360e(c)(4) of this title is withdrawn after a second or subsequent portion is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the portions submitted.

(vi) Sole discretion to refund

The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.

(3) Annual establishment registration fee

(A) In general

Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 360 of this title beginning with its registration for fiscal year 2008.

(B) Exception

No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act 1 [25 U.S.C. 5301 et seq.]), unless a device manufactured by the establishment is to be distributed commercially.

(C) Payment

The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—

(i) the initial or annual registration (as applicable) of the establishment under section 360 of this title; or

(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(b) Fee Amounts

(1) In general

Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).

(2) Base fee amounts specified

For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:

Fee TypeFiscal Year 2018Fiscal Year 2019Fiscal Year 2020Fiscal Year 2021Fiscal Year 2022
Premarket Application $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration $4,375 $4,548 $4,760 $4,975 $4,978

(3) Total revenue amounts specified

For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

(A) $183,280,756 for fiscal year 2018.

(B) $190,654,875 for fiscal year 2019.

(C) $200,132,014 for fiscal year 2020.

(D) $211,748,789 for fiscal year 2021.

(E) $213,687,660 for fiscal year 2022.

(c) Annual fee setting; adjustments

(1) In general

The Secretary shall, 60 days before the start of each fiscal year after September 30, 2017, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.

(2) Inflation adjustments

(A) Adjustment to total revenue amounts

For fiscal year 2018 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.

(B) Applicable inflation adjustment

The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of—

(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and

(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2016.

(C) Base inflation adjustment

(i) In general

Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—

(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by 0.60; and

(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by 0.40.

(ii) Limitations

For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—

(I) is less than 1, such adjustment shall be considered to be equal to 1; or

(II) is greater than 1.04, such adjustment shall be considered to be equal to 1.04.

(D) Adjustment to base fee amounts

For each of fiscal years 2018 through 2022, the Secretary shall—

(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and

(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).

(3) Volume-based adjustments to establishment registration base fees

For each of fiscal years 2018 through 2022, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be increased, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).

(4) Limit

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.

(5) Supplement

(A) In general

The Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of the next fiscal year.

(B) Notice to Congress

Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.

(d) Small businesses; fee waiver and fee reduction regarding premarket approval fees

(1) In general

The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term "small business" means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).

(2) Rules relating to premarket approval fees

(A) Definition

For purposes of this paragraph, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(B) Evidence of qualification

(i) In general

An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate.

(ii) Firms submitting tax returns to the United States Internal Revenue Service

The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.

(C) Reduced fees

Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—

(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and

(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.

(D) Request for fee waiver or reduction

An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.

(e) Small businesses; fee reduction regarding premarket notification submissions

(1) In general

For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(viii) may be paid at a reduced rate in accordance with paragraph (2)(C).

(2) Rules relating to premarket notification submissions

(A) Definition

For purposes of this subsection, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(B) Evidence of qualification

(i) In general

An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate.

(ii) Firms submitting tax returns to the United States Internal Revenue Service

The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.

(C) Reduced fees

For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 25 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).

(D) Request for reduction

An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.

(f) Effect of failure to pay fees

(1) No acceptance of submissions

A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.

(2) No registration

Registration information submitted under section 360 of this title by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 360 of this title.

(g) Conditions

(1) Performance goals; termination of program

With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—

(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $320,825,000 multiplied by the adjustment factor applicable to such fiscal year; or

(B) fees were not assessed under subsection (a) for the previous fiscal year.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(3) Limitation

Beginning on October 1, 2023, the authorities under section 379i(9)(C) of this title shall include only leasing and necessary scientific equipment.

(h) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and

(ii) shall be available to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.

(B) Compliance

(i) In general

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of device applications—

(I) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(II)(aa) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and

(bb) such costs are not more than 5 percent below the level specified in such subparagraph.

(ii) More than 5 percent

To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.

(C) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorizations of appropriations

For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c).

(i) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(j) Written requests for refunds

To qualify for consideration for a refund under subsection (a)(2)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.

(k) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(June 25, 1938, ch. 675, §738, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108–214, §2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat. 572, 576, 577; Pub. L. 109–43, §2(a), Aug. 1, 2005, 119 Stat. 439; Pub. L. 110–85, title II, §212, Sept. 27, 2007, 121 Stat. 844; Pub. L. 112–144, title II, §203(a)–(f), July 9, 2012, 126 Stat. 1002; Pub. L. 112–193, §2(b)(1), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title II, §203(a)–(f)(1), (2)(B)–(i), title IX, §905(b)(2), Aug. 18, 2017, 131 Stat. 1013–1016, 1090.)

Termination of Section

For termination of section by section 210(a) of Pub. L. 115–52, see Effective and Termination Dates note below.

References in Text

The Indian Self Determination and Educational Assistance Act, referred to in subsec. (a)(3)(B), probably means the Indian Self-Determination and Education Assistance Act, Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

Amendments

2017—Subsec. (a)(1). Pub. L. 115–52, §203(a)(1), substituted "fiscal year 2018" for "fiscal year 2013".

Subsec. (a)(2)(A). Pub. L. 115–52, §203(f)(2)(B)(ii), substituted "(d) and (e)" for "(d), (e), and (f)" in introductory provisions.

Pub. L. 115–52, §203(a)(2)(A)(i), substituted "October 1, 2017" for "October 1, 2012" in introductory provisions.

Subsec. (a)(2)(A)(viii). Pub. L. 115–52, §203(a)(2)(A)(ii), substituted "3.4 percent" for "2 percent".

Subsec. (a)(2)(A)(xi). Pub. L. 115–52, §203(a)(2)(A)(iii), added cl. (xi).

Subsec. (a)(2)(B)(v)(I). Pub. L. 115–52, §203(a)(2)(B), substituted "premarket notification submission, or de novo classification request" for "or premarket notification submission".

Subsec. (a)(3)(A). Pub. L. 115–52, §203(f)(2)(B)(iii), struck out "and subsection (f)" after "subparagraph (B)".

Subsec. (b). Pub. L. 115–52, §203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2013 to 2017.

Subsec. (c)(1). Pub. L. 115–52, §203(c)(1), substituted "2017" for "2012".

Subsec. (c)(2)(A). Pub. L. 115–52, §203(c)(2)(A), substituted "2018" for "2014".

Subsec. (c)(2)(B). Pub. L. 115–52, §203(c)(2)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: "The applicable inflation adjustment for a fiscal year is—

"(i) for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and

"(ii) for fiscal year 2015 and each subsequent fiscal year, the product of—

"(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and

"(II) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014."

Subsec. (c)(2)(C). Pub. L. 115–52, §203(c)(2)(C), struck out "to total revenue amounts" after "adjustment" in heading.

Subsec. (c)(2)(D). Pub. L. 115–52, §203(c)(2)(D), amended subpar. (D) generally. Prior to amendment, text read as follows: "For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A)."

Subsec. (c)(3). Pub. L. 115–52, §203(c)(3), substituted "2018 through 2022" for "2014 through 2017" and "increased" for "further adjusted".

Subsec. (d)(1). Pub. L. 115–52, §203(d)(1), substituted "specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)" for "specified in clauses (i) through (v) and clauses (vii), (ix), and (x)".

Subsec. (d)(2)(C)(i). Pub. L. 115–52, §203(d)(2), substituted "supplement," for "supplement, or" and inserted ", or a de novo classification request" after "class III device".

Subsec. (e)(2)(C). Pub. L. 115–52, §203(e), substituted "25 percent" for "50 percent".

Subsec. (f). Pub. L. 115–52, §203(f)(1), (2)(B)(i), redesignated subsec. (g) as (f) and struck out former subsec. (f) which authorized the Secretary to grant waivers or reductions of fees under subsec. (a)(2) or (3) until Oct. 1, 2017.

Subsec. (f)(1). Pub. L. 115–52, §203(g), substituted "periodic reporting concerning a class III device, or de novo classification request" for "or periodic reporting concerning a class III device" and "all such fees" for "all fees".

Subsec. (g). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).

Subsec. (g)(1)(A). Pub. L. 115–52, §203(h), substituted "$320,825,000" for "$280,587,000".

Subsec. (h). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).

Subsec. (h)(3). Pub. L. 115–52, §203(i)(1), substituted "2018 through 2022" for "2013 through 2017" and "subsection (c)." for "subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4)."

Pub. L. 115–52, §905(b)(2), added par. (3), effective Aug. 18, 2017. Subsec. (h) subsequently redesignated (g) effective Oct. 1, 2017, by Pub. L. 115–52, §203(f)(2)(B)(i). See Amendment note above.

Subsec. (h)(4). Pub. L. 115–52, §203(i)(2), struck out par. (4). Text read as follows: "If the cumulative amount of fees collected during fiscal years 2013, 2014, and 2015, added to the amount estimated to be collected for fiscal year 2016, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2016, exceeds the cumulative amount appropriated pursuant to paragraph (3) for these four fiscal years, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017."

Subsecs. (i) to (l). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsecs. (j) to (l) as (i) to (k), respectively. Former subsec. (i) redesignated (h).

2012—Subsec. (a)(1). Pub. L. 112–144, §203(a)(1), substituted "fiscal year 2013" for "fiscal year 2008".

Subsec. (a)(2)(A). Pub. L. 112–144, §203(a)(2)(A), substituted "subsections (d), (e), and (f)" for "subsections (d) and (e)", "October 1, 2012" for "October 1, 2002", and "subsection (c)" for "subsection (c)(1)" in introductory provisions.

Subsec. (a)(2)(A)(viii). Pub. L. 112–144, §203(a)(2)(B), substituted "2" for "1.84".

Subsec. (a)(3)(A). Pub. L. 112–144, §203(a)(3)(A), inserted "and subsection (f)" after "subparagraph (B)".

Subsec. (a)(3)(C). Pub. L. 112–144, §203(a)(3)(B), substituted "later of—" for "initial registration of the establishment or upon the annual registration under section 360 of this title." and added cls. (i) and (ii).

Subsec. (b). Pub. L. 112–144, §203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2008 to 2012.

Subsec. (c). Pub. L. 112–144, §203(c), inserted "; adjustments" after "setting" in heading, added pars. (1) to (3), redesignated former pars. (3) and (4) as (4) and (5), respectively, and struck out former pars. (1) and (2) which related to annual publication and adjustment of fees.

Subsecs. (f) to (h). Pub. L. 112–144, §203(d), added subsec. (f) and redesignated former subsecs. (f) and (g) as (g) and (h), respectively. Former subsec. (h) redesignated (i).

Subsec. (h)(1)(A). Pub. L. 112–144, §203(e), substituted "$280,587,000" for "$205,720,000".

Subsec. (i). Pub. L. 112–144, §203(d)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j).

Subsec. (i)(1). Pub. L. 112–144, §203(f)(1), substituted "Subject to paragraph (2)(C), fees authorized" for "Fees authorized".

Subsec. (i)(2)(A)(i). Pub. L. 112–144, §203(f)(2)(A)(i), substituted "subject to subparagraph (C), shall be collected and available" for "shall be retained".

Subsec. (i)(2)(A)(ii). Pub. L. 112–193 substituted "shall be available" for "shall only be available".

Pub. L. 112–144, §203(f)(2)(A)(ii), substituted "shall only be available" for "shall only be collected and available" and "fiscal year 2009" for "fiscal year 2002".

Subsec. (i)(2)(C). Pub. L. 112–144, §203(f)(2)(B), added subpar. (C).

Subsec. (i)(3). Pub. L. 112–144, §203(f)(3), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2008 to 2012.

Subsec. (i)(4). Pub. L. 112–144, §203(f)(4), substituted "fiscal years 2013, 2014, and 2015" for "fiscal years 2008, 2009, and 2010", "fiscal year 2016" for "fiscal year 2011", "June 30, 2016" for "June 30, 2011", "the cumulative amount appropriated pursuant to" for "the amount of fees specified in aggregate in", and "fiscal year 2017" for "fiscal year 2012" and struck out "aggregate amount in" before "excess shall be credited".

Subsecs. (j) to (l). Pub. L. 112–144, §203(d)(1), redesignated subsecs. (i) to (k) as (j) to (l), respectively.

2007—Subsec. (a)(1). Pub. L. 110–85, §212(a)(1)(A), substituted "Beginning in fiscal year 2008" for "Beginning on October 26, 2002".

Subsec. (a)(2). Pub. L. 110–85, §212(a)(1)(B), amended heading generally. Prior to amendment, heading read as follows: "Premarket application, premarket report, supplement, and submission fee".

Subsec. (a)(2)(A)(iii). Pub. L. 110–85, §212(a)(2)(A), substituted "a fee equal to 75 percent of the fee that applies" for "a fee equal to the fee that applies".

Subsec. (a)(2)(A)(iv). Pub. L. 110–85, §212(a)(2)(B), substituted "15 percent" for "21.5 percent".

Subsec. (a)(2)(A)(v). Pub. L. 110–85, §212(a)(2)(C), substituted "7 percent" for "7.2 percent".

Subsec. (a)(2)(A)(vi), (vii). Pub. L. 110–85, §212(a)(2)(D), (E), added cl. (vi) and redesignated former cl. (vi) as (vii). Former cl. (vii) redesignated (viii).

Subsec. (a)(2)(A)(viii). Pub. L. 110–85, §212(a)(2)(D), (F), redesignated cl. (vii) as (viii), substituted "1.84 percent" for "1.42 percent", and struck out ", subject to any adjustment under subsection (e)(2)(C)(ii) of this section" before period at end.

Subsec. (a)(2)(A)(ix), (x). Pub. L. 110–85, §212(a)(2)(G), added cls. (ix) and (x).

Subsec. (a)(2)(C). Pub. L. 110–85, §212(a)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: "The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and October 26, 2002, shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section 360e(c)(3) of this title shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003."

Subsec. (a)(2)(D)(iii). Pub. L. 110–85, §212(a)(4)(A), struck out at end "The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable."

Subsec. (a)(2)(D)(iv) to (vi). Pub. L. 110–85, §212(a)(4)(B), added cls. (iv) to (vi).

Subsec. (a)(3). Pub. L. 110–85, §212(a)(5), added par. (3).

Subsec. (b). Pub. L. 110–85, §212(b), amended subsec. (b) generally. Prior to amendment, text read as follows: "Except as provided in subsections (c), (d), (e), (g), and (h) of this section, the fees under subsection (a) of this section shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; and $29,785,000 in fiscal year 2005. If legislation is enacted after October 26, 2002, requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications."

Subsec. (c). Pub. L. 110–85, §212(c)(1)(A), made technical amendment to heading.

Subsec. (c)(1). Pub. L. 110–85, §212(c)(1)(B), struck out at end "The fees established for fiscal year 2006 shall be based on a premarket application fee of $259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600."

Subsec. (c)(2), (3). Pub. L. 110–85, §212(c)(2)(A), (B), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 110–85, §212(c)(2)(A), (C), redesignated par. (3) as (4) and substituted in subpar. (A) "The Secretary" for "For fiscal years 2006 and 2007, the Secretary" and "for the first month of the next fiscal year" for "for the first month of fiscal year 2008".

Subsec. (d)(1). Pub. L. 110–85, §212(d)(1), struck out ", partners, and parent firms" after "affiliates" and substituted "clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)" for "clauses (i) through (vi) of subsection (a)(2)(A) of this section".

Subsec. (d)(2)(A). Pub. L. 110–85, §212(d)(2)(A), struck out ", partners, and parent firms" before period at end.

Subsec. (d)(2)(B). Pub. L. 110–85, §212(d)(2)(B)(i), (ii), designated first sentence as cl. (i) and second to fourth sentences as cl. (ii) and inserted cl. headings.

Subsec. (d)(2)(B)(ii). Pub. L. 110–85, §212(d)(2)(B)(iii), (iv), struck out ", partners, and parent firms" after "its affiliates" and after "such affiliates" and substituted "If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates." for "If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively."

Subsec. (d)(2)(B)(iii). Pub. L. 110–85, §212(d)(2)(B)(v), added cl. (iii).

Subsec. (d)(2)(C). Pub. L. 110–85, §212(d)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: "Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) of this section may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement."

Subsec. (e)(1). Pub. L. 110–85, §212(e)(1), substituted "2008" for "2004" and "(a)(2)(A)(viii)" for "(a)(2)(A)(vii)".

Subsec. (e)(2)(A). Pub. L. 110–85, §212(e)(2)(A), struck out ", partners, and parent firms" before period at end.

Subsec. (e)(2)(B). Pub. L. 110–85, §212(e)(2)(B)(i), (ii), inserted cl. headings and designated first sentence as cl. (i) and second to fourth sentences as cl. (ii).

Subsec. (e)(2)(B)(ii). Pub. L. 110–85, §212(e)(2)(B)(iii), (iv), struck out ", partners, and parent firms" after "its affiliates" and after "such affiliates" and substituted "If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates." for "If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively."

Subsec. (e)(2)(B)(iii). Pub. L. 110–85, §212(e)(2)(B)(v), added cl. (iii).

Subsec. (e)(2)(C). Pub. L. 110–85, §212(e)(3), amended subpar. (C) generally. Prior to amendment, subpar. (C) contained provisions, for fiscal year 2004 and each subsequent fiscal year, authorizing in cl. (i) a reduced fee for a premarket notification submission, and directing in cl. (ii) the Secretary how to determine an adjustment per fee revenue amount.

Subsec. (f). Pub. L. 110–85, §212(f), amended subsec. (f) generally. Prior to amendment, text read as follows: "A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid."

Subsec. (g)(1). Pub. L. 110–85, §212(g)(1), added par. (1) and struck out former par. (1). Prior to amendment, par. (1) related to performance goals for fiscal years 2003 through 2005, with respect to the amount appropriated under the salaries and expenses account of the Food and Drug Administration, for devices and radiological products, and termination of the program after fiscal year 2005.

Subsec. (g)(2). Pub. L. 110–85, §212(g)(2), amended par. (2) generally. Prior to amendment, text read as follows: "If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of subparagraph (C) or (D) of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid."

Subsec. (h)(3). Pub. L. 110–85, §212(h)(1), amended par. (3) generally, substituting provisions authorizing appropriations for fiscal years 2008 to 2012 for provisions authorizing appropriations for fiscal years 2003 to 2007.

Subsec. (h)(4). Pub. L. 110–85, §212(h)(2), amended par. (4) generally. Prior to amendment, text read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

2005—Subsec. (a)(2)(A). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)".

Subsec. (b). Pub. L. 109–43, §2(a)(1), inserted "and" after "2004;" and substituted "2005" for "2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal year 2007".

Subsec. (c). Pub. L. 109–43, §2(a)(2)(A), substituted "Annual fee setting" for "Adjustments" in heading.

Subsec. (c)(1). Pub. L. 109–43, §2(a)(2)(B)–(D), redesignated par. (5) as (1), substituted "In general" for "Annual fee setting" in heading, "publish in the Federal Register fees under subsection (a) of this section. The fees" for "establish, for the next fiscal year, and publish in the Federal Register, fees under subsection (a) of this section, based on the revenue amounts established under subsection (b) of this section and the adjustment provided under this subsection and subsection (e)(2)(C)(ii) of this section, except that the fees", "2006" for "2003", and "$259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600." for "$154,000." in text, and struck out former par. (1) which required an annual inflation adjustment of the revenues established in subsec. (b).

Subsec. (c)(2). Pub. L. 109–43, §2(a)(2)(B), (C), redesignated par. (6) as (2) and struck out former par. (2) which required an annual adjustment of the fee revenues established in subsec. (b) to reflect changes in the workload of the Secretary for the process for the review of device applications.

Subsec. (c)(3). Pub. L. 109–43, §2(a)(2)(B), (E), added par. (3) and struck out former par. (3) which required an annual compensating adjustment of the fee revenues established in subsec. (b).

Subsec. (c)(4). Pub. L. 109–43, §2(a)(2)(B), struck out par. (4) which provided for a fiscal year 2007 adjustment of the fee revenues established in subsec. (b) to provide for operating reserves of carryover user fees.

Subsec. (c)(5), (6). Pub. L. 109–43, §2(a)(2)(C), redesignated pars. (5) and (6) as (1) and (2), respectively.

Subsec. (d)(1). Pub. L. 109–43, §2(a)(3)(A), inserted after first sentence "For the purposes of this paragraph, the term 'small business' means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms."

Subsec. (d)(2)(A). Pub. L. 109–43, §2(a)(3)(B), struck out cl. (i) designation and heading before "For purposes", substituted "paragraph," for "subsection," and "$100,000,000" for "$30,000,000", and struck out heading and text of clause (ii). Text read as follows: "The Secretary may adjust the $30,000,000 threshold established in clause (i) if the Secretary has evidence from actual experience that this threshold results in a reduction in revenues from premarket applications, premarket reports, and supplements that is 16 percent or more than would occur without small business exemptions and lower fee rates. To adjust this threshold, the Secretary shall publish a notice in the Federal Register setting out the rationale for the adjustment, and the new threshold."

Subsec. (d)(2)(C). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)".

Subsec. (e)(2)(A). Pub. L. 109–43, §2(a)(4), substituted "$100,000,000" for "$30,000,000".

Subsec. (e)(2)(C). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)" in cls. (i) and (ii).

Subsec. (g)(1)(B)(i). Pub. L. 109–43, §2(a)(5)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows: "For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is equal to or greater than the sum of—

"(I) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2003;

"(II) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2004; and

"(III) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2005."

Subsec. (g)(1)(B)(ii). Pub. L. 109–43, §2(a)(5)(A)(ii), added introductory provisions and struck out former introductory provisions which read as follows: "For fiscal year 2005, if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is less than the sum that applies under clause (i) for fiscal year 2005, the following applies:".

Subsec. (g)(1)(C). Pub. L. 109–43, §2(a)(5)(B)(i), substituted "2005 and" for "2003 through" and inserted "more than 1 percent" after "years, is".

Subsec. (g)(1)(C)(ii). Pub. L. 109–43, §2(a)(5)(B)(ii), substituted "amount that applies" for "sum that applies".

Subsec. (g)(1)(D)(i). Pub. L. 109–43, §2(a)(5)(C), inserted "more than 1 percent" after "year, is".

Subsec. (h)(3)(D), (E). Pub. L. 109–43, §2(a)(6), added subpar. (D) and struck out former subpars. (D) and (E) which read as follows:

"(D) $32,615,000 for fiscal year 2006; and

"(E) $35,000,000 for fiscal year 2007,".

2004Pub. L. 108–214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, §102(a), which enacted this section.

Subsec. (a). Pub. L. 108–214, §2(d)(2)(A), designated introductory provisions of subsec. (a) as par. (1), inserted heading, substituted "this section." for "this section as follows:", and redesignated former par. (1) as (2).

Subsec. (a)(1)(A). Pub. L. 108–214, §2(a)(2)(A)(i), substituted, in introductory provisions, "subsections (d) and (e)" for "subsection (d)", in cl. (iv), "clause (i)" for "clause (i), subject to any adjustment under subsection (c)(3) of this section", and, in cl. (vii), "clause (i), subject to any adjustment under subsection (e)(2)(C)(ii)" for "clause (i), subject to any adjustment under subsection (c)(3) of this section and any adjustment under subsection (e)(2)(C)(ii)".

Subsec. (a)(1)(D)(i), (ii). Pub. L. 108–214, §2(a)(2)(A)(ii), substituted "application, report," for "application".

Subsec. (d)(1). Pub. L. 108–214, §2(d)(2)(B)(i), substituted "subsection (a)(2)(A)" for "subsection (a)(1)(A)" in last sentence.

Subsec. (d)(2)(B). Pub. L. 108–214, §2(a)(2)(B), substituted "firms, which show" for "firms. which show" in second sentence.

Subsec. (e)(1). Pub. L. 108–214, §2(a)(2)(C)(i), (d)(2)(B)(ii), substituted "For fiscal year 2004 and each subsequent fiscal year, where" for "Where" and "subsection (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)".

Subsec. (e)(2)(B). Pub. L. 108–214, §2(a)(2)(C)(ii)(I), substituted "firms, which show" for "firms. which show".

Subsec. (e)(2)(C). Pub. L. 108–214, §2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted "For fiscal year 2004 and each subsequent fiscal year, where" for "Where" in cl. (i), "subsection (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)" in cls. (i) and (ii), and "subsection (a)(2)(A)(i)" for "subsection (a)(1)(A)(i)" in cl. (ii).

Subsec. (f). Pub. L. 108–214, §2(a)(2)(D), struck out "for filing" after "accepted".

Subsec. (h)(2)(B). Pub. L. 108–214, §2(a)(2)(E), designated existing provisions as cl. (i), inserted heading, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as items (aa) and (bb), respectively, of cl. (i)(II), and added cl. (ii).

Subsec. (j). Pub. L. 108–214, §2(d)(2)(B)(iv), substituted "subsection (a)(2)(D)" for "subsection (a)(1)(D)".

Effective Date of 2017 Amendment

Amendment by section 203 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in subsection (a)(2)(A) of this section received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2022, see section 210(a) of Pub. L. 115–52, set out as a note under section 379i of this title.

Section effective Oct. 26, 2002, except for certain premarket fees, see section 106 of Pub. L. 107–250, set out as a note under section 379i of this title.

Fee Exemption for Certain Entities Submitting Premarket Reports

Pub. L. 107–250, title I, §102(b), Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 108–214, §2(d)(2)(C), (3)(B), Apr. 1, 2004, 118 Stat. 577, provided that: "A person submitting a premarket report to the Secretary of Health and Human Services is exempt from the fee under section 738(a)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j(a)(2)(A)(ii)] (as added by subsection (a) of this section) if—

"(1) the premarket report is the first such report submitted to the Secretary by the person; and

"(2) before October 1, 2002, the person submitted a premarket application to the Secretary for the same device as the device for which the person is submitting the premarket report."

1 See References in Text note below.

§379j–1. Reauthorization; reporting requirements

(a) Reports

(1) Performance report

(A) In general

(i) General requirements

Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(ii) Additional information

Beginning with fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—

(I) the number of premarket applications filed under section 360e of this title per fiscal year for each review division;

(II) the number of reports submitted under section 360(k) of this title per fiscal year for each review division; and

(III) the number of expedited development and priority review designations under section 360e–3 1 of this title per fiscal year.

(iii) Real time reporting

(I) In general

Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph.

(II) Data

The Secretary shall post the following data in accordance with subclause (I):

(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017; and

(bb) The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.

(iv) 2 Rationale for MDUFA program changes

Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

(I) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and

(III) for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.

(iv) 2 Analysis

For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:

(I) The difference between the aggregate number of premarket applications filed under section 360e of this title and aggregate reports submitted under section 360(k) of this title and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—

(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

(bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.


(II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.

(III) The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.

(B) Publication

With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b).

(C) Updates

The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.

(2) Corrective action report

Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(A) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process.

(B) Goals missed

For each of the goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(i) a justification for such determination;

(ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under section 360e of this title or notifications submitted under section 360(k) of this title missed the review goal times but were approved during the first cycle review, as applicable;

(iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and

(iv) the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such 3 fiscal year.

(3) Enhanced communication

(A) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(B) Participation in congressional hearing

Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.

(4) Fiscal report

For fiscal years 2018 through 2022, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

(5) Public availability

The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.

(b) Reauthorization

(1) Consultation

In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2022, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a)(1);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(5) Transmittal of recommendations

Not later than January 15, 2022, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6) Minutes of negotiation meetings

(A) Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.

(B) Content

The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §738A, as added Pub. L. 110–85, title II, §213, Sept. 27, 2007, 121 Stat. 850; amended Pub. L. 112–144, title II, §204, July 9, 2012, 126 Stat. 1006; Pub. L. 115–52, title II, §204, title IX, §§903(b), 904(b), Aug. 18, 2017, 131 Stat. 1016, 1078, 1083.)

Termination of Section

For termination of section by section 210(b) of Pub. L. 115–52, see Effective and Termination Dates note below.

References in Text

Section 201(b) of the Medical Device User Fee Amendments of 2017, referred to in subsec. (a)(1)(A), (B), (2), is section 201(b) of Pub. L. 115–52, which is set out as a note under section 379i of this title.

Section 360e–3 of this title, referred to in subsec. (a)(1)(A)(ii)(III), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, §901(f)(2), Aug. 18, 2017, 131 Stat. 1077.

Amendments

2017—Subsec. (a)(1)(A). Pub. L. 115–52, §903(b), designated existing provisions as cl. (i), inserted heading, and added cls. (ii), (iii), and (iv) related to rationale for MDUFA program changes.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §204(a)(1)(A), substituted "2018" for "2013" and "the Medical Device User Fee Amendments of 2017" for "the Medical Device User Fee Amendments of 2012".

Subsec. (a)(1)(A)(iv). Pub. L. 115–52, §904(b)(1), added cl. (iv) relating to analysis to be included in report.

Subsec. (a)(1)(B). Pub. L. 115–52, §204(a)(1)(B), substituted "the Medical Device User Fee Amendments of 2017" for "the Medical Device User Fee Amendments Act of 2012".

Subsec. (a)(2), (3). Pub. L. 115–52, §904(b)(2)(B), added pars. (2) and (3). Former pars. (2) and (3) redesignated (4) and (5), respectively.

Subsec. (a)(4). Pub. L. 115–52, §904(b)(2)(A), redesignated par. (2) as (4).

Pub. L. 115–52, §204(a)(2), which directed amendment of par. (2), effective Oct. 1, 2017, by substituting "2018 through 2022" for "2013 through 2017", was executed by making the substitution in par. (4) to reflect the probable intent of Congress and the redesignation of par. (2) as (4), effective Aug. 18, 2017, by Pub. L. 115–52, §904(b)(2)(A). See Amendment note above.

Subsec. (a)(5). Pub. L. 115–52, §904(b)(2)(A), redesignated par. (3) as (5).

Subsec. (b)(1). Pub. L. 115–52, §204(b)(1), substituted "2022" for "2017" in introductory provisions.

Subsec. (b)(5). Pub. L. 115–52, §204(b)(2), substituted "2022" for "2017".

2012—Subsec. (a)(1). Pub. L. 112–144, §204(b)(1), added par. (1) and struck out former par. (1). Prior to amendment, text read as follows: "For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort."

Subsec. (a)(2). Pub. L. 112–144, §204(b)(2), substituted "2013 through 2017" for "2008 through 2012".

Subsec. (b)(1). Pub. L. 112–144, §204(a)(1), substituted "2017" for "2012".

Subsec. (b)(5). Pub. L. 112–144, §204(a)(2), substituted "2017" for "2012".

Effective Date of 2017 Amendment

Amendment by section 204 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective and Termination Dates

Pub. L. 115–52, title II, §210(b), Aug. 18, 2017, 131 Stat. 1020, provided that: "Section 738A (21 U.S.C. 739j–1 [379j–1]) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2023."

Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.

1 See References in Text note below.

2 So in original. Two cls. (iv) have been enacted.

3 So in original.