For Immediate Release
Office of the Press Secretary
October 28, 2002
Statement by the President
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.
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