Page:United States Statutes at Large Volume 116 Part 2.djvu/806

 116 STAT. 1588 PUBLIC LAW 107-250—OCT. 26, 2002 Public Law 107-250 107th Congress Oct. 26, 2002 [H.R. 5651] Medical Device User Fee and Modernization Act of 2002. 21 USC 301 note. An Act To amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) SHORT TITLE. —This Act may be cited as the "Medical Device User Fee and Modernization Act of 2002". (b) TABLE OF CONTENTS.— The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—FEES RELATED TO MEDICAL DEVICES Sec. 101. Findings. Sec. 102. Establishment of program. Sec. 103. Annual reports. Sec. 104. Postmarket surveillance. Sec. 105. Consultation. Sec. 106. Effective date. Sec. 107. Sunset clause. TITLE II—AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES Sec. 201, Inspections by accredited persons. Sec. 202. Third party review of premarket notification. Sec. 203. Debarment of accredited persons. Sec. 204. Designation and regulation of combination products. Sec. 205. Report on certain devices. Sec. 206. Electronic labeling. Sec. 207. Electronic registration. Sec. 208. Intended use. Sec. 209. Modular review. Sec. 210. Pediatric expertise regarding classification-panel review of premarket applications. Sec. 211. Internet list of class II devices exempted from requirement of premarket notification. Sec. 212. Study by Institute of Medicine of postmarket siuveillance regarding pediatric populations. Sec. 213. Guidance regarding pediatric devices. Sec. 214. Breast implants; study by Comptroller General. Sec. 215. Breast implants; research through National Institutes of Health. TITLE III—ADDITIONAL AMENDMENTS Sec. 301. Identification of manufacturer of medical devices. Sec. 302. Single-use medical devices. Sec. 303. MedWatch.

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