[Federal Register Volume 71, Number 226 (Friday, November 24, 2006)]
[Notices]
[Pages 67879-67881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0451]


Guidance for Industry, Food and Drug Administration Staff, Eye 
Care Professionals, and Consumers; Decorative, Non-Corrective Contact 
Lenses; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance for Industry, FDA 
Staff, Eye Care Professionals, and Consumers: Decorative, Non-
Corrective Contact Lenses.'' This guidance document explains recently 
enacted legislation under which all contact lenses are deemed devices 
within the meaning of the Federal Food, Drug, and Cosmetic Act (the 
act). All contact lenses, including decorative, non-corrective contact 
lenses, require premarket approval or clearance by FDA and may be 
dispensed only upon a lawful prescription order by an eye care 
professional. Although this guidance document is being immediately 
implemented, the agency welcomes comments at any time in accordance 
with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document

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entitled ``Guidance for Industry, FDA Staff, Eye Care Professionals, 
and Consumers: Decorative, Non-Corrective Contact Lenses'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 240-276-3151. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ernest N. Smith, Center for Devices 
and Radiological Health (HFZ-331), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 240-276-0115.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance outlines FDA's current thinking on the application of 
device requirements to decorative, non-corrective contact lenses under 
the act. Decorative, non-corrective contact lenses are intended to 
change the normal appearance of the eye, such as to make brown eyes 
appear green. Although some of these products are covered by premarket 
notifications (510(k)s) filed under section 510(k) of the act (21 
U.S.C. 360(k)) or premarket approval applications (PMAs) filed under 
section 515 of the act (21 U.S.C. 360e), other products have been sold 
without FDA premarket review and have been labeled for distribution 
without a prescription, proper fitting by a qualified eye care 
professional, and ongoing professional supervision.
    Decorative, non-corrective contact lenses, like all other contact 
lenses, can cause a variety of eye injuries or conditions. For example, 
lens wear has been associated with corneal ulcers, conjunctivitis, and 
allergic reactions. Because of these risks, contact lenses, including 
decorative, non-corrective contact lenses, are not safe for use except 
under the supervision of a qualified eye care professional licensed by 
law to direct the use of such devices.
    President Bush signed Public Law 109-96 into law on November 9, 
2005. The legislation provides that ``[a]ll contact lenses shall be 
deemed to be devices under section 201(h) [of the act].'' The Senate 
report that accompanied the bill that became Public Law No. 109-96 
explains the basis for this legislation. ``Some non-corrective, 
decorative contact lenses have not been approved by FDA and are sold 
without a prescription. Previously, FDA regulated these non-corrective 
contact lenses under its cosmetic authority in chapter VI of the [act]. 
These contact lenses present a public health threat. S. Rep. 109-110, 
at 2 (2005).''
    As a result of this legislation, decorative contact lenses that are 
not the subject of an approved PMA, cleared 510(k), or exemption for 
investigational use are in violation of federal law. Specifically, such 
devices are adulterated under section 501(f)(1)(B) of the act (21 
U.S.C. 351(f)(1)(B)) and misbranded under section 502(o) of the act (21 
U.S.C. 352(o)). Adulterated and misbranded devices are subject to 
enforcement action under the act, including seizure, injunction, and 
civil money penalties. Manufacturers, distributors, and importers of 
non-corrective contact lenses that are not currently approved or 
cleared by FDA should cease distribution of the devices and submit the 
appropriate application or submission to FDA for approval or clearance 
if they wish to distribute non-corrective contact lenses. Guidance for 
510(k) submissions and PMA applications for contact lenses is available 
at http://www.fda.gov/cdrh/devadvice/3122.html. Non-corrective contact 
lenses are also subject to general controls, including the Quality 
System regulation (QS regulation, part 820 (21 CFR part 820)).
    FDA is implementing this guidance document immediately because 
prior public participation is not feasible or appropriate due to the 
need to provide guidance to implement Public Law 109-96, which was 
effective upon enactment on November 9, 2005.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGP regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on decorative, non-corrective contact lenses regulated as devices. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Decorative, Non-Corrective Contact 
Lenses'' you may either send an e-mail request to [email protected] to 
receive an electronic copy of the document or send a fax request to 
240-276-3151 to receive a hard copy. Please use the document number 
1613 to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 820 have been approved under OMB 
control number 0910-0073, the collections of information in 21 CFR part 
812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 807 have been approved under 
OMB control number 0910-0120; the collections of information in 21 CFR 
part 814 have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments.

[[Page 67881]]

Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 15, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-19887 Filed 11-22-06; 8:45 am]
BILLING CODE 4160-01-S