39–010 

Calendar No. 177 

109TH CONGRESS REPORT " ! SENATE 1st Session 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 

JULY 27, 2005.—Ordered to be printed 

Mr. ENZI, from the Committee on Health, Education, Labor, and 

Pensions, submitted the following 

R E P O R T 

[To accompany S. 172] 

The Committee on Health, Education, Labor, and Pensions, to 

which was referred the bill (S. 172) 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, having considered the same, reports favorably thereon with an amendment in 

the nature of a substitute and recommends that the bill (as amended) do pass. 

CONTENTS 

Page 

I. Purpose and summary ................................................................................... 1 

II. Background and need for legislation ............................................................ 2 

III. Legislative history and committee action .................................................... 2 

IV. Explanation of bill and committee views ..................................................... 2 

V. Cost estimate .................................................................................................. 3 

VI. Application of law to the legislative branch ................................................ 4 

VII. Regulatory impact statement ........................................................................ 5 

VIII. Section-by-section analysis ............................................................................ 5 

IX. Changes in existing law ................................................................................ 5 

I. PURPOSE AND SUMMARY OF THE BILL

The purpose of S.172 is to provide for the regulation of all contact lenses as medical devices. S. 172 amends Section 520 of the 

Federal Food, Drug, and Cosmetic Act (FFDCA) by adding a subsection (n) that deems all contact lenses to be medical devices 

under Section 201(h) of the FFDCA. 

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II. BACKGROUND AND NEED FOR LEGISLATION

‘‘Plano’’ contact lenses are zero powered, non-corrective contact 

lenses that are used to change the appearance of the normal eye 

in a decorative fashion. Most contact lenses currently marketed in 

the United States, including certain plano and decorative contact 

lenses, have been cleared as medical devices pursuant to premarket 

notifications under Section 510(k) of the FFDCA by the Food and 

Drug Administration (FDA). The FDA has asserted medical device 

jurisdiction over most corrective and noncorrective contact lenses 

currently marketed in the United States, including certain plano 

and decorative contact lenses, so as to require approval pursuant 

to premarket approval applications under Section 515 of the 

FFDCA or clearance pursuant to premarket notifications for dispensing pursuant to the lawful prescriptions of eye care professionals. 

However, some non-corrective, decorative contact lenses have not 

been approved by FDA and are sold without a prescription. The 

FDA regulates these non-corrective contact lenses under its cosmetic authority in Chapter VI of the FFDCA. These contact lenses 

present a public health threat. 

One such example involved a teenage girl from Cleveland who 

bought colored contact lenses from a video rental store for the purpose of matching her eyes with her dress. The lenses were sold 

without fitting or instruction. Shortly after wearing the colored 

contact lenses, she was admitted to a Cleveland hospital where her 

left eye become so badly infected the doctor feared that she might 

not only lose her sight, but she could actually lose her eye. She was 

in the intensive care unit for 4 days. 

The problem is national in scale. Contact lens insertion without 

appropriate supervision and fitting has been linked to ocular ulcers, as well as temporary and permanent vision problems. In Wyoming, Dr. Roger Jordan of Gillette reported a personal experience 

with a teenager who came in to see him with vision problems that 

resulted from an unlicensed person giving her plano lens that she 

put over her corrective lenses. 

III. LEGISLATIVE HISTORY AND COMMITTEE ACTION

On January 26, 2005, Senator DeWine, for himself and Senator 

Kennedy, introduced S. 172, to provide for the regulation of all contact lenses as medical devices. On March 9, 2005, the committee 

held an executive session to consider S. 172. After accepting an 

amendment in the nature of a substitute, the committee approved 

S. 172, as amended, by unanimous voice vote. 

IV. EXPLANATION OF BILL AND COMMITTEE VIEWS

There is an overwhelming public health consensus that it is necessary for these products to be regulated as medical devices. However, because the companies marketing these plano lenses, mostly 

importers, have avoided making health claims for their products, 

the FDA regulates them as cosmetics, not medical devices. The 

committee’s action is not intended to create law for or against 

FDA’s regulatory approach in this case. S. 172 achieves this result 

by including a rule of construction providing that the bill’s subVerDate Aug 04 2004 12:44 Aug 08, 2005 Jkt 039010 PO 00000 Frm 00002 Fmt 6659 Sfmt 6602 E:\HR\OC\SR110.XXX SR110
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stantive provision shall not be construed as having any legal effect 

on any other article regulated under the FFDCA. 

S. 172 automatically deems all contact lenses to be medical devices under the Federal Food, Drug, and Cosmetic Act (‘‘FDCA’’) to 

ensure that all contact lenses are properly manufactured and used 

only with the appropriate involvement of a qualified eye care professional while avoiding any complex legal or policy issues. In the 

highly regulated arena of products governed by the FFDCA, such 

product-focused legislation is not unusual. Thus, for example, in 

1990, Congress enacted specific medical device provisions relating 

to daily wear soft and nonhydrophilic plastic contact lenses. S. 172 

achieves a similar outcome by addressing unanticipated developments in the marketplace with respect to one particular form of 

contact lens. 

V. COST ESTIMATE

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, April 15, 2005. 

Hon. MICHAEL B. ENZI, 

Chairman, Committee on Health, Education, Labor, and Pensions, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 172, 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. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Julia Christensen. 

Sincerely, 

ELIZABETH M. ROBINSON

(For Douglas Holtz-Eakin, Director). 

Enclosure 

S. 172—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 

S. 172 would amend the Federal Food, Drug, and Cosmetic Act 

(FDCA) to require that the Food and Drug Administration (FDA) 

regulate all contact lens products as medical devices. 

FDA currently regulates all contact lenses as medical devices except for decorative, noncorrective lenses, which FDA currently regulates as cosmetics. S. 172 would deem all contact lenses to be 

medical devices under the FDCA. Based on information from FDA, 

CBO expects that the additional cost for FDA to regulate decorative contact lenses as medical devices beyond its cost to regulate 

such products as cosmetics under current law would be negligible. 

Assuming the availability of appropriated amounts, CBO estimates 

that implementing S. 172 would cost FDA less than $500,000 annually. 

CBO expects that changing the regulatory classification of decorative, non-corrective lenses to medical devices would likely lead to 

FDA requiring that those products be available only by prescription. (For decorative, non-corrective lenses, a prescription-only label 

would require the oversight of an eye care professional to ensure 

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proper fitting and use.) In response, we anticipate that the Federal 

Trade Commission (FTC) would expand its regulation of prescription contact lenses to include decorative non-corrective contact 

lenses. Based on information provided by the FTC, CBO estimates 

that implementing S. 172 would not have a significant impact on 

spending subject to appropriation for that agency. 

The legislation would not affect direct spending. There would be 

potential for higher revenues through penalties imposed by FDA 

and the FTC for violations of Federal laws under their respective 

jurisdictions related to contact lenses. Such collections of civil penalties are recorded in the budget as revenues. However, based on 

information provided by the agencies, CBO expects that revenues 

from any penalties collected as a result of enacting S. 172 would 

be negligible. 

S. 172 contains no intergovernmental mandates as defined in the 

Unfunded Mandates Reform act (UMRA) and would impose no 

costs on state, local, or tribal governments. However, the bill would 

impose private-sector mandates on sellers, prescribers and manufacturers of decorative non-corrective lenses by making them subject to more stringent federal regulatory requirements for medical 

devices. CBO estimates that the direct costs of the mandates in the 

bill would not exceed the threshold established in UMRA ($123 

million in 2005, adjusted annually for inflation) in any of the first 

5 years the mandate would be effective. 

A mandate would be imposed on sellers and prescribers because, 

as medical devices, such contact lenses would more likely require 

prescription verification. CBO expects that prescribers of decorative, non-corrective lenses would have to provide the patient with 

a copy of the prescription and to verify the prescription to thirdparty manufacturers. Since eye care professionals need only return 

the call of a third-party manufacturer if the prescription the manufacturer has is wrong, CBO estimates that the costs to these entities would be insignificant. 

S. 172 also would impose a private-sector mandate on manufacturers. Based on information from industry and government 

sources, CBO estimates that most major manufacturers already 

produce decorative, non-corrective contact lenses under standards 

that would meet the tighter FDA requirements. For the remaining 

manufacturers, CBO estimates that the cost of upgrading production processes and obtaining FDA approval would not be significant. 

The CBO staff contacts for this estimate are Julia Christensen 

and Melissa Zimmerman, for the Federal budget impact, Leo Lex, 

for the State and local impact and Meena Fernandes, for the private-sector impact. This estimate was approved by Peter H. 

Fontaine, Deputy Assistant Director for Budget Analysis. 

VI. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

S. 172 amends Section 520 of the FFDCA to deem all contact 

lenses to be medical devices. As such, it has no application to the 

legislative branch. 

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VII. REGULATORY IMPACT STATEMENT

The legislation amends Section 520 of the FFDCA to deem all 

contact lenses to be medical devices. Decorative lenses now regulated as cosmetics would be regulated as medical devices, requiring 

that they be available only by prescription and the oversight of a 

qualified eye care professional to ensure proper fitting and use. Accordingly, CBO anticipate S. 172 will result in a slight increase in 

cost to the public. CBO anticipates that the Federal Trade Commission will expand its regulation of prescription contact lenses to include all decorative, non-corrective contact lenses. CBO estimates 

that implementing S. 172 would not have a significant impact on 

spending subject to appropriation for that agency. Pursuant to the 

requirements of paragraph 11(b) of Rule XXVI of the Standing 

Rules of the Senate, the committee has determined that the bill 

will not have a significant regulatory impact. 

VIII. SECTION-BY-SECTION ANALYSIS

Sec. 1. Findings 

Sec. 2. Regulation of certain articles as medical devices 

Section 2 amends Section 520 of the FFDCA by adding a new 

subsection (n). Paragraph (1) of the new section 520(n) deems all 

contact lenses to be medical devices. 

Paragraph (2) of the new section 520(n) makes clear that paragraph (1) does not have any legal effect on any article other than 

a contact lens. 

IX. CHANGES IN EXISTING LAW

In compliance with rule XXVI paragraph 12 of the Standing 

Rules of the Senate, the following provides a print of the statute 

or the part or section thereof to be amended or replaced (existing 

law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed 

is shown in roman): 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * * 

GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED

FOR HUMAN USE

General Rule 

Sec. 520. (a) Any requirement authorized by or under section 

501, 502, 510, or 519 applicable to a device intended for human use 

shall apply to such device until the applicability of the requirement 

to the device has been changed by action taken under section 513, 

514, or 515 or under subsection (g) of this section, and any requirement established by or under section 501, 502, 510, or 519 which 

is inconsistent with a requirement imposed on such device under 

section 514 or 515 or under subsection (g) of this section shall not 

apply to such device. 

* * * * * * * 

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(m)(1) To the extent consistent with the protection of the public 

health and safety and with ethical standards, it is the purpose of 

this subsection to encourage the discovery and use of devices intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the 

United States. 

(2) The Secretary may grant a request for an exemption from the 

effectiveness requirements of sections 514 and 515 for a device for 

which the Secretary finds that— 

(A) * * * 

* * * * * * * 

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 subject to such paragraph. 

* * * * * * * 

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