Page:United States Statutes at Large Volume 104 Part 6.djvu/132

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104 STAT. 4522 PUBLIC LAW 101-629—NOV. 28, 1990 "(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) 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. 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 sufQcient 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.". SEC. 11. USE OF PREMARKET APPROVAL DATA. Section 520 (21 U.S.C. 360j) is amended— (1) in subsection (c)— (A) by striking out "under section 513 from class III to class II and inserting in lieu thereof "from class III to class II or class I", and (B) by inserting "(1) in accordance with subsection (h), and (2) after "except", and (2) in subsection (h)— (A) in paragraph (3), by striking out "Any" and inserting in lieu thereof "Except as provided in paragraph (4), any', and (B) by adding at the end the following new paragraph: "(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c), including clinical and preclinical tests or studies, but excluding descriptions of methods of manufacture and product composition, that demonstrates the safety and effectiveness of a device shall be available 1 year sifter the original application for the fourth device of a kind has been approved by the Secretary, for use by the Secretary in approving devices, or determining whether a product development protocol has been completed, under section 515, establishing a performance standard under section 514, and reclassifying devices under subsections (e) and (f) of section 513, and subsection (1)(2). The Secretary shall deem devices that incorporate the same technologies, have the same principles of operation, and are intended for the same use or uses to be within a kind of device. ^^•"^ "(B) The Secretary, contemporaneously with the approval of the wtion fourth device of a kind, shall publish an order in the Federal Register identif3ring the four devices of a kind that have been approved under section 515 and the date on which the data contained in premarket approval applications for the devices will be available to the Secretary for use, as described in subparagraph (A). "(C) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by para-