[The House version of the bill was introduced by Rep. John Boozman,
R-AR, on January 26, 2005, and then was referred to the House Committee on Energy and Commerce.
Status: Passed on October 26, 2005.]
One Hundred Ninth Congress
of the
United States of America
IN THE HOUSE OF REPRESENTATIVES JANUARY 26, 2005
Mr. BOOZMAN (for himself and Mr. WAXMAN) 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 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.
SECTION 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.''.
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