Page:United States Statutes at Large Volume 119.djvu/459

 PUBLIC LAW 109–43—AUG. 1, 2005

119 STAT. 441

‘‘(D) such sums as may be necessary for each of fiscal years 2006 and 2007.’’; and (7) by striking ‘‘subsection (c)(5)’’ each place it appears and inserting ‘‘subsection (c)(1)’’. (b) ANNUAL REPORTS.—Section 103 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250 (116 Stat. 1600)) is amended— (1) by striking ‘‘Beginning with’’ and inserting ‘‘(a) IN GENERAL.—Beginning with’’; and (2) by adding at the end the following: ‘‘(b) ADDITIONAL INFORMATION.—For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include— ‘‘(1) information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and ‘‘(2) a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) of section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not less than such amounts for fiscal year 2002 multiplied by the adjustment factor, as defined in paragraph (7) of such section 737.’’. (c) MISBRANDED DEVICES.— (1) IN GENERAL.—Section 502(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(u)) is amended to read as follows: ‘‘(u)(1) Subject to paragraph (2), if it is a reprocessed singleuse device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the reprocessed device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer. ‘‘(2) If the original device or an attachment thereto does not prominently and conspicuously bear 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, a reprocessed device may satisfy the requirements of paragraph (1) through the use of a detachable label on the packaging that identifies the manufacturer and is intended to be affixed to the medical record of a patient.’’. (2) GUIDANCE.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance to identify circumstances in which 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, is not ‘‘prominent and conspicuous’’, as used in section 502(u) of Federal Food, Drug, and Cosmetic Act (as amended by paragraph (1)). (d) EFFECTIVE DATE.—Section 301(b) of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250 (116 Stat. 1616)), as amended by section 2(c) of Public Law 108– 214 (118 Stat. 575), is amended to read as follows:

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21 USC 379i note.

Certification.

Labeling.

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21 USC 352 note.

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