[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2218 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 2218

 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
 regulation of noncorrective contact lens as medical devices, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 22, 2003

  Mr. Boozman (for himself, Mr. Waxman, Mr. Norwood, Mr. Snyder, Mr. 
   Fletcher, Mr. Weldon of Florida, Mr. Burgess, and Mr. Bilirakis) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
 regulation of noncorrective contact lens as medical devices, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. FINDINGS.

    The Congress finds as follows:
            (1) Both corrective and noncorrective contact lenses have 
        significant effects on the eye and pose serious potential 
        health risks if improperly manufactured or used without the 
        supervision of a qualified eyecare practitioner.
            (2) Noncorrective lenses sold outside the protections of 
        medical device regulation have caused eye injuries in children.
            (3) Both corrective and noncorrective lenses have been 
        approved as medical devices by the Food and Drug Administration 
        (``FDA'').
            (4) FDA has until recently publicly claimed jurisdiction 
        over both corrective and noncorrective contact lenses as 
        medical devices.

SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL DEVICES.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended by adding at the end the following subsection:

                ``Regulation of Contact Lens as Devices

    ``(n)(1) Both corrective and noncorrective contact lenses and 
similar articles shall be considered devices under section 201(h).
    ``(2) With respect to an article that is not described in paragraph 
(1), such paragraph may not be construed as having any legal effect on 
any determination by the Secretary of whether the article is a food, a 
drug, a device, or a cosmetic.''.
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