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[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 172 Reported in Senate (RS)]

                                                       Calendar No. 177
109th CONGRESS
  1st Session
                                 S. 172

                          [Report No. 109-110]

 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.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            January 26, 2005

    Mr. DeWine (for himself, Mr. Kennedy, Mr. Enzi, Mr. Dorgan, Ms. 
   Collins, Mr. Harkin, Mr. Burr, Mr. Bunning, Mr. Corzine, and Mr. 
  Voinovich) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

                             July 27, 2005

                Reported by Mr. Enzi, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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.

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

<DELETED>SECTION 1. FINDINGS.</DELETED>

<DELETED>    Congress finds as follows:</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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'').</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED>SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL 
              DEVICES.</DELETED>

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

       <DELETED>``Regulation of Contact Lens as Devices</DELETED>

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

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 subject to such paragraph.''.
                                                       Calendar No. 177

109th CONGRESS

  1st Session

                                 S. 172

                          [Report No. 109-110]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             July 27, 2005

                       Reported with an amendment
```