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 Home > News & Policies > October 2002

For Immediate Release
Office of the Press Secretary
October 28, 2002

President's Statement on H.R. 5651, the "Medical Device User Fee and Modernization Act of 2002"

Today I have signed into law H.R. 5651, the "Medical Device User Fee and Modernization Act of 2002." The Act protects patients from inappropriate reuse of medical devices, strengthens the inspection regime for medical device manufacturing facilities, modernizes Food and Drug Administration (FDA) medical device operations, and establishes a program under which the users of the FDA's medical device review services pay for those services.

Section 201(a) of the Act enacts section 704(g)(10) of the Food Drug and Cosmetic Act, which purports to make the operation of the "accredited persons" inspection provisions for medical device establishments dependent upon certain determinations by the Comptroller General, a legislative agent, of amounts obligated by the Secretary of Health and Human Services for particular purposes. The executive branch shall construe this provision in accordance with the principles set forth in Bowsher v. Synar, 478 U.S. 714 (1986).

Several provisions of the Act require executive branch officials to submit recommendations to the Congress. The executive branch shall construe such provisions in a manner consistent with the President's constitutional authority to submit for the consideration of the Congress such measures as the President judges necessary and expedient.

October 26, 2002

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