    [Public Papers of the Presidents of the United States: George W. Bush (2002, Book II)]
    [October 26, 2002]
    [Page 1912]
    [From the U.S. Government Publishing Office www.gpo.gov]

    [[Page 1912]]

    Statement on Signing the Medical Device User Fee and Modernization Act
    of 2002
    October 26, 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.

                                                              George W. Bush

     The White House,

     October 26, 2002.

    Note: H.R. 5651, approved October 26, was assigned Public Law No. 107-
    250. This statement was released by the Office of the Press Secretary on
    October 28.