[Congressional Record Volume 151, Number 6 (Wednesday, January 26, 2005)]
[Senate]
[Page S580]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DeWINE (for himself and Mr. Kennedy):
  S. 172. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
provide for the regulation of all contact lenses as medical devices, 
and for other purposes; to the Committee on Health, Education, Labor, 
and Pensions.
  Mr. DeWINE. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 172

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

     SECTION 1. FINDINGS.

       Congress finds as follows:
       (1) All contact lenses have significant effects on the eye 
     and pose serious potential health risks if improperly 
     manufactured or used without appropriate involvement of a 
     qualified eye care professional.
       (2) Most contact lenses currently marketed in the United 
     States, including certain plano and decorative contact 
     lenses, have been approved as medical devices pursuant to 
     premarket approval applications or cleared pursuant to 
     premarket notifications by the Food and Drug Administration 
     (``FDA'').
       (3) FDA has asserted medical device jurisdiction over most 
     corrective and noncorrective contact lenses as medical 
     devices currently marketed in the United States, including 
     certain plano and decorative contact lenses, so as to require 
     approval pursuant to premarket approval applications or 
     clearance pursuant to premarket notifications.
       (4) All contact lenses can present risks if used without 
     the supervision of a qualified eye care professional. Eye 
     injuries in children and other consumers have been reported 
     for contact lenses that are regulated by FDA as medical 
     devices primarily when used without professional involvement, 
     and noncorrective contact lenses sold without approval or 
     clearance as medical devices have caused eye injuries in 
     children.

     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:

                ``Regulation of Contact Lens as Devices

       ``(n)(1) All contact lenses shall be deemed to be devices 
     under section 201(h).
       ``(2) Paragraph 1 shall not be construed as having any 
     legal effect on any article that is not described in that 
     paragraph.''.
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