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.

        [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.