Page:United States Statutes at Large Volume 116 Part 2.djvu/834

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116 STAT. 1616 PUBLIC LAW 107-250—OCT. 26, 2002 breast implants, both gel and saline filled. Such research studies may include the following: "(1) Developing and examining techniques to measure concentrations of silicone in body fluids and tissues. "(2) Surveillance of recipients of silicone breast implants, including long-term outcomes and local complications. "(b) DEFINITION. — For purposes of this section, the term 'breast implant' means a breast prosthesis that is implanted to augment or reconstruct the female breast.". TITLE III—ADDITIONAL AMENDMENTS SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES. (a) IN GENERAL. —Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: "(u) If it is a device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, except that the Secretary may waive any requirement under this paragraph for the device if the Secretary determines that compliance with the requirement is not feasible for the device or would compromise the provision of reasonable assurance of the safety or effectiveness of the device.". 21 USC 352 note. (b) EFFECTIVE DATE. —The amendment made by subsection (a) takes effect 18 months after the date of the enactment of this Act, and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date. SEC. 302. SINGLE-USE MEDICAL DEVICES. (a) REQUIRED STATEMENTS ON LABELING.— (1) IN GENERAL.— Section 502 of the Federal Food, Drug, and Cosmetic Act, as amended by section 301 of this Act, is amended by adding at the end the following: "(v) If it is a reprocessed single-use device, unless all labeling of the device prominently and conspicuously bears the statement 'Reprocessed device for single use. Reprocessed by .' The name of the manufacturer of the reprocessed device shall be placed in the space identifying the person responsible for reprocessing.". (2) EFFECTIVE DATE.—The amendment made by paragraph (1) takes effect 15 months after the date of the enactment of this Act, and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date. 21 USC 352 note. (b) PREMARKET NOTIFICATION. —Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by inserting after subsection (n) the following: "(o)(1) With respect to reprocessed single-use devices for which reports are required under subsection (k): "(A) The Secretary shall identify such devices or types of devices for which reports under such subsection must, in order to ensure that the device is substantially equivalent to a predicate device, include validation data, the t3^es of which shall be specified by the Secretary, regarding cleaning and sterilization, and functional performance demonstrating