[United States Statutes at Large, Volume 119, 109th Congress, 1st Session]
[From the U.S. Government Publishing Office, www.gpo.gov]

119 STAT. 2119

Public Law 109-96
109th Congress

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.  NOTE: Nov. 9, 2005 -  [S. 172]

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).''.

Approved November 9, 2005.

LEGISLATIVE HISTORY--S. 172:
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SENATE REPORTS: No. 109-110 (Comm. on Health, Education, Labor, and
Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
July 29, considered and passed Senate.
Oct. 26, considered and passed House.