Page:United States Statutes at Large Volume 104 Part 6.djvu/125

 PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4515 (i) require appropriate methods for maintenance of records to ensure that patients who receive devices can be provided the notification required by such Act, (ii) require that manufacturers adopt effective methods of tracking devices, (iii) take into account the position of distributors in the device distribution process, and (iv) include such other requirements as the Secretary deems necessary for the adoption of an effective user tracking program under section 519(e) of such Act. (2) Not later than 18 months after the date of the enactment of this Act, the Secretary shall issue final regulations to implement sections 519(a)(6) and 519(e) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations upon the expiration of such 18 months, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of sections 519(a)(6) and 519(e) of such Act are essential to protect the health of patients who use such devices. Consequently, in such event, the proposed regulations issued under paragraph (1) shall become final regulations as of the expiration of such 18 months. There shall be Federal promptly published in the Federal Register notice of the new pubiic|[-on status of the proposed regulations. SEC. 4. SUBSTANTIAL EQUIVALENCE; CLASSIFICATION REVISION. (a) SUBSTANTIAL EQUIVALENCE.—Section 513(f) (21 U.S.C. 360c(f)) is amended by adding at the end the following: "(3) If a manufacturer reports to the Secretary under section 510(k) that a device is substantially equivalent to another device— "(i) which the Secretary has classified as a class III device under subsection (b), "(ii) which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990, and "(iii) for which no final regulation requiring premarket approval has been promulgated under section 5150b), the manufacturer shall certify to the Secretary that the manufacturer has conducted a reasonable search of all information known or otherwise available to the manufacturer respecting such other device and has included in the report under section 510(k) a summary of and a citation to all adverse safety and effectiveness data respecting such other device and respecting the device for which the 510(k) report is being made and which has not been submitted to the Secretary under section 519. The Secretary may require the manufacturer to submit the adverse safety and effectiveness data described in the report.". (b) REVISION OF CLASSIFICATION.— (1) Section 515 (21 U.S.C. 360e) is amended by adding at the end the following: "Revision "(i)(l) Before December 1, 1995, the Secretary shall by order require manufacturers of devices, which were introduced or delivered for introduction into interstate commerce for commercial dis-

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