POSTMARKET SURVEILLANCE.

SEC. 104. POSTMARKET SURVEILLANCE. (a) Additional Authorization of Appropriations.—For the purpose of carrying out postmarket surveillance of medical devices, 116 STAT. 1601there are authorized to be appropriated to the Food and Drug Administration the following amounts, stated as increases above the amount obligated for such purpose by such Administration for fiscal year 2002: (1) For fiscal year 2003, an increase of $3,000,000. (2) For fiscal year 2004, an increase of $6,000,000. (3) For fiscal year 2005 and each subsequent fiscal year, an increase of such sums as may be necessary. (b) Study.— (1) In general.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a study for the purpose of determining the following with respect to the medical device user-fee program established under the amendment made by section 102: (A) The impact of such program on the ability of the Food and Drug Administration to conduct postmarket surveillance on medical devices. (B) The programmatic improvements, if any, needed for adequate postmarket surveillance of medical devices. (C) The amount of funds needed to conduct adequate postmarket surveillance of medical devices. (D) The extent to which device companies comply with the postmarket surveillance requirements, including postmarket study commitments. (E) The recommendations of the Secretary as to whether, and in what amounts, user fees collected under such user-fee program should be dedicated to postmarket surveillance if the program is extended beyond fiscal year 2007. (2) Report.—Not later than January 10, 2007, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that describes the findings of the study under paragraph (1).