106 STAT. 238 PUBLIC LAW 102-300~ -JUNE 16, 1992 Public Law 102-300 102d Congress An Act June 16.1992 [S. 2788] Medical Device Amendments of 1992. Safety. 21 USC 301 note. Federal Register, publication. 21 USC 360i note. To amend the Federal Food, Drug, and Cosmetic Act with respect to medical devices and for other purposes. Be it enacted by the Senate and House of Representatives of the United States cfAmerica in Congress assembled, SECTION 1. SHORT TITLE AND REFERENCE. (a) SHORT TITLE. — This Act may be cited as the 'Medical Device Amendments of 1992". (b) REFERENCE. —Whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. SEC. 2. EFFECTIVE DATE AND REGULATIONS TO IBfPLEBIENT DEVICE TRACKING. (a) AMENDMENT.—Section 3 of the Safe Medical Devices Act of 1990 (21 U.S.C. 360i note) is amended— (1) in subsection (b)(3), by striking out "upon the effective date" and inserting in lieu thereof "iMn the expiration of 9 months after the issuance"; (2) in subsection (c)(2)— (A) by striking out "and 519(er the first place it occurs; and (B) by striking out "and 519(e) of sudi Act are" and inserting in lieu uiereof "of such Act is"; and (3) by adding at the end of subsection (c) the following: "(3) Not later than November 28, 1992, the Secretary shall issue final regulations to implement section 519(e) of the Federal Food, Drue, and Cosmetic Act If the Secretary does not promulgate such final relations by November 28, 1992, the Congress finds that there is good cause for the proposed r^;ulations to be considered as the final regulations without response to comment because the implementotion of section 519(e) of such Act is essential to protect the health of patients who use devices. In such event, the proposed regulations issued under paragraph (1) shall become the issued nnal regulations on NovemTOr 29, 1992. There shall be promptlv published in the Federal Register notice of the new status of the proposed ranilations.". (b) EFFECTIVE DATE.— The amendments made by subsection (a) shall take effect as of May 27, 1992 and any rule to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act proposed under section 3(c)(2) of the Safe Medical Devices Act of 1990 shall revert to its proposed status as of such date. SBC. S. P08TMARKET SURVEILLANCE. (a) PROHIBITED ACT.—
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