108th CONGRESS
  1st Session
                                H. R. 2218

_______________________________________________________________________

                                 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. FINDINGS.

    The 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 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 having any legal effect
on any article that is not described in that paragraph.''.

            Passed the House of Representatives November 19, 2003.