§360l. Postmarket surveillance

(a) In general

(1) Required surveillance

The Secretary shall require a manufacturer to conduct postmarket surveillance for any device of the manufacturer first introduced or delivered for introduction into interstate commerce after January 1, 1991, that-

(A) is a permanent implant the failure of which may cause serious, adverse health consequences or death,

(B) is intended for a use in supporting or sustaining human life, or

(C) potentially presents a serious risk to human health.

(2) Discretionary surveillance

The Secretary may require a manufacturer to conduct postmarket surveillance for a device of the manufacturer if the Secretary determines that postmarket surveillance of the device is necessary to protect the public health or to provide safety or effectiveness data for the device.

(b) Surveillance approval

Each manufacturer required to conduct a surveillance of a device under subsection (a)(1) of this section shall, within 30 days of the first introduction or delivery for introduction of such device into interstate commerce, submit, for the approval of the Secretary, a protocol for the required surveillance. 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. The Secretary, within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of useful data or other information necessary to protect the public health and to provide safety and effectiveness information for the device. The Secretary may not approve such a protocol until it has been reviewed by an appropriately qualified scientific and technical review committee established by the Secretary.

(June 25, 1938, ch. 675, §522, as added Nov. 28, 1990, Pub. L. 101–629, §10, 104 Stat. 4521 ; amended June 16, 1992, Pub. L. 102–300, §3(b), 106 Stat. 239 .)

Amendments

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."

Section Referred to in Other Sections

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