Page:United States Statutes at Large Volume 119.djvu/460

 119 STAT. 442

Applicability.

PUBLIC LAW 109–43—AUG. 1, 2005

‘‘(b) EFFECTIVE DATE.—Section 502(u) of the Federal Food, Drug, and Cosmetic Act (as amended by section 2(c) of the Medical Device User Fee Stabilization Act of 2005)— ‘‘(1) shall be effective— ‘‘(A) with respect to devices described under paragraph (1) of such section, 12 months after the date of enactment of the Medical Device User Fee Stabilization Act of 2005, or the date on which the original device first bears the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, whichever is later; and ‘‘(B) with respect to devices described under paragraph (2) of such section 502(u), 12 months after such date of enactment; and ‘‘(2) shall apply only to devices reprocessed and introduced or delivered for introduction in interstate commerce after such applicable effective date.’’. Approved August 1, 2005.

LEGISLATIVE HISTORY—H.R. 3423 (S. 1420): SENATE REPORTS: No. 109–107 accompanying S. 1420 (Comm. on Health, Education, Labor, and Pensions). CONGRESSIONAL RECORD, Vol. 151 (2005): July 26, considered and passed House. July 27, considered and passed Senate.

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