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.

(This measure has not been amended since it was passed by the Senate on July 29, 2005. The summary of that version is repeated here.)

Deems all contact lenses to be medical devices under the Federal Food, Drug, and Cosmetic Act. (Currently, some non-corrective, decorative contact lenses are regulated as cosmetics).

[109th Congress Public Law 96]
[From the U.S. Government Publishing Office]


[DOCID: f:publ096.109]

[[Page 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:
---------------------------------------------------------------------------

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.

                                  <all>