II 

Calendar No. 177 

109TH CONGRESS 

1ST SESSION S. 172 

[Report No. 109–110] 

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. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 26, 2005 

Mr. DEWINE (for himself, Mr. KENNEDY, Mr. ENZI, Mr. DORGAN, Ms. COLLINS, Mr. HARKIN, Mr. BURR, Mr. BUNNING, Mr. CORZINE, and Mr. 

VOINOVICH) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

JULY 27, 2005 

Reported by Mr. ENZI, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. FINDINGS. 

4 Congress finds as follows: 
2 

•S 172 RS 

1 (1) All contact lenses have significant effects on 

2 the eye and pose serious potential health risks if im3 properly manufactured or used without appropriate 

4 involvement of a qualified eye care professional. 

5 (2) Most contact lenses currently marketed in 

6 the United States, including certain plano and deco7 rative contact lenses, have been approved as medical 

8 devices pursuant to premarket approval applications 

9 or cleared pursuant to premarket notifications by 

10 the Food and Drug Administration (‘‘FDA’’). 

11 (3) FDA has asserted medical device jurisdic12 tion over most corrective and noncorrective contact 

13 lenses as medical devices currently marketed in the 

14 United States, including certain plano and decora15 tive contact lenses, so as to require approval pursu16 ant to premarket approval applications or clearance 

17 pursuant to premarket notifications. 

18 (4) All contact lenses can present risks if used 

19 without the supervision of a qualified eye care pro20 fessional. Eye injuries in children and other con21 sumers have been reported for contact lenses that 

22 are regulated by FDA as medical devices primarily 

23 when used without professional involvement, and 

24 noncorrective contact lenses sold without approval or 
3 

•S 172 RS 

1 clearance as medical devices have caused eye injuries 

2 in children. 

3 SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL 

4 DEVICES. 

5 Section 520 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360j) is amended by adding at the end 

7 the following: 

8 ‘‘Regulation of Contact Lens as Devices 

9 ‘‘(n)(1) All contact lenses shall be deemed to be de10 vices under section 201(h). 

11 ‘‘(2) Paragraph 1 shall not be construed as having 

12 any legal effect on any article that is not described in that 

13 paragraph.’’. 

14 SECTION 1. FINDINGS. 

15 Congress finds as follows: 

16 (1) All contact lenses have significant effects on 

17 the eye and pose serious potential health risks if im18 properly manufactured or used without appropriate 

19 involvement of a qualified eye care professional. 

20 (2) Most contact lenses currently marketed in the 

21 United States, including certain plano and decorative 

22 contact lenses, have been approved as medical devices 

23 pursuant to premarket approval applications or 

24 cleared pursuant to premarket notifications by the 

25 Food and Drug Administration (‘‘FDA’’). 
4 

•S 172 RS 

1 (3) FDA has asserted medical device jurisdiction 

2 over most corrective and noncorrective contact lenses 

3 as medical devices currently marketed in the United 

4 States, including certain plano and decorative contact 

5 lenses, so as to require approval pursuant to pre6 market approval applications or clearance pursuant 

7 to premarket notifications. 

8 (4) All contact lenses can present risks if used 

9 without the supervision of a qualified eye care profes10 sional. Eye injuries in children and other consumers 

11 have been reported for contact lenses that are regu12 lated by FDA as medical devices primarily when used 

13 without professional involvement, and noncorrective 

14 contact lenses sold without approval or clearance as 

15 medical devices have caused eye injuries in children. 

16 SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL 

17 DEVICES. 

18 Section 520 of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 360j) is amended by adding at the end the 

20 following: 

21 ‘‘Regulation of Contact Lens as Devices 

22 ‘‘(n)(1) All contact lenses shall be deemed to be devices 

23 under section 201(h). 
5 

•S 172 RS 

1 ‘‘(2) Paragraph (1) shall not be construed as having 

2 any legal effect on any article that is not subject to such 

3 paragraph.’’. 
Calendar No. 177 

109TH CONGRESS 

1ST SESSION S. 172 

[Report No. 109–110] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

lenses as medical devices, and for other purposes. Act to provide for the regulation of all contact 

JULY 27, 2005 

Reported with an amendment