118 STAT. 572 PUBLIC LAW 108–214—APR. 1, 2004 Public Law 108–214 108th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Moderniza tion Act of 2002, 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. This Act may be cited as the ‘‘Medical Devices Technical Correc tions Act’’. SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107–250. (a) TITLE I; FEES RELATING TO MEDICAL DEVICES.—Part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as added by section 102 of Public Law 107–250 (116 Stat. 1589), is amended— (1) in section 737— (A) in paragraph (4)(B), by striking ‘‘and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness’’ and inserting ‘‘and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness’’; (B) in paragraph (4)(D), by striking ‘‘manufacturing,’’; (C) in paragraph (5)(J), by striking ‘‘a premarket application’’ and all that follows and inserting ‘‘a premarket application or premarket report under section 515 or a premarket application under section 351 of the Public Health Service Act.’’; and (D) in paragraph (8), by striking ‘‘The term ‘affiliate’ means a business entity that has a relationship with a second business entity’’ and inserting ‘‘The term ‘affiliate’ means a business entity that has a relationship with a second business entity (whether domestic or international)’’; and (2) in section 738— (A) in subsection (a)(1)— (i) in subparagraph (A)— (I) in the matter preceding clause (i) by striking ‘‘subsection (d),’’ and inserting ‘‘sub sections (d) and (e),’’; (II) in clause (iv), by striking ‘‘clause (i),’’ and all that follows and inserting ‘‘clause (i).’’; and 21 USC 379j. 21 USC 379i. 21 USC 301 note. Medical Devices Technical Corrections Act. Apr. 1, 2004 [S. 1881]
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