[Federal Register: November 24, 2006 (Volume 71, Number 226)]
[Notices]
[Page 67879-67881]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no06-75]
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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
[[Page 67880]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 dsmica@fda.hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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