§360l. Postmarket surveillance

(a) In general

The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be-

(1) implanted in the human body for more than one year, or

(2) a life sustaining or life supporting device used outside a device user facility.

(b) Surveillance approval

Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the manufacturer is required under this section to conduct such surveillance, submit, for the approval of the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated to conduct the surveillance has appropriate qualifications and experience to undertake such surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health. The Secretary, in consultation with the manufacturer, may by order require a prospective surveillance period of up to 36 months. Any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the manufacturer or, if no agreement can be reached, after the completion of a dispute resolution process as described in section 360bbb–1 of this title.

(June 25, 1938, ch. 675, §522, as added Pub. L. 101–629, §10, Nov. 28, 1990, 104 Stat. 4521 ; amended Pub. L. 102–300, §3(b), June 16, 1992, 106 Stat. 239 ; Pub. L. 105–115, title II, §212, Nov. 21, 1997, 111 Stat. 2346 .)

Amendments

1997-Pub. L. 105–115 amended section generally, substituting present provisions for former provisions which related to required surveillance, discretionary surveillance, and surveillance approval.

1992-Subsec. (b). Pub. L. 102–300 substituted "(a)(1)" for "(a)", inserted comma after "commerce", and inserted after first sentence "Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) of this section shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance."

Effective Date of 1997 Amendment

Section 212 of Pub. L. 105–115 provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.

Section Referred to in Other Sections

This section is referred to in sections 331, 352 of this title.