[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 172 Enrolled Bill (ENR)]


        S.172

                       One Hundred Ninth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
            the fourth day of January, two thousand and five


                                 An Act


 
  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.

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

SECTION 1. 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) All contact lenses shall be deemed to be devices under 
section 201(h).
    ``(2) Paragraph (1) shall not be construed as bearing on or being 
relevant to the question of whether any product other than a contact 
lens is a device as defined by section 201(h) or a drug as defined by 
section 201(g).''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.