[Weekly Compilation of Presidential Documents Volume 38, Number 44 (Monday, November 4, 2002)]
[Page 1874]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
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.