[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Pages 28052-28053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13535]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0183]
Bausch & Lomb, Inc.; Premarket Approval of Bausch &
Lomb Soflens66TM (alphafilcon A) Visibility Tinted
Contact Lens for Extended Wear
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Bausch & Lomb, Inc., Rochester, NY, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the BAUSCH & LOMB SofLens66TM
(alphafilcon A) Visibility Tinted Contact Lens for Extended Wear. FDA's
Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of December 16, 1996, of the approval of the
application.
DATES: Petitions for administrative review by June 23, 1997.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: James F. Saviola, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1744.
SUPPLEMENTARY INFORMATION: On June 28, 1996, Bausch & Lomb, Inc.,
Rochester, NY 14692-0450, submitted to CDRH an application for
premarket approval of the BAUSCH & LOMB
SofLens66TM (alphafilcon A) Visibility Tinted Contact Lens
for Extended Wear. The device is a soft (hydrophilic) contact lens and
is indicated for daily wear or extended wear from 1 to 7 days between
removals for cleaning and disinfection or disposal of lens, as
recommended by the eye care practitioner. The lens is indicated for the
correction of refractive ametropia (myopia and hyperopia) in not-
aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00
diopters or less, that does not interfere with visual acuity.
In accordance with the provisions of section 515(c)(2) of the act
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of
1990, this application was not referred to the Ophthalmic Devices Panel
of the Medical Devices Advisory Committee, an FDA advisory committee,
for review and recommendation because the information in the
application substantially duplicates information previously reviewed by
this panel.
On December 16, 1996, CDRH approved the application by a letter to
the applicant from the Director of the Office of Device Evaluation,
CDRH.
A summary of the safety and effectiveness data on which CDRH based
its approval is on file in the Dockets Management Branch (address
above) and is available from that office upon written request. Requests
should be identified with the name of the device and the docket number
found in brackets in the heading of this document.
The labeling of the BAUSCH & LOMB SofLens66TM
(alphafilcon A) Visibility Tinted Contact Lens for Extended Wear states
that the lens is to be used only with certain solutions for
disinfection and other purposes. The restrictive labeling informs new
users that they must avoid using certain products, such as solutions
intended for use with hard contact lenses only.
Opportunity for Administrative Review
Section 515(d)(3) of the act authorizes any interested person to
petition, under section 515(g) of the act, for administrative review of
CDRH's decision to approve this application. A petitioner may request
either a formal hearing under 21 CFR part 12 of FDA's administrative
practices and procedures regulations or a review of the application and
CDRH's action by an independent advisory committee of experts. A
petition is to be in the form of a petition for reconsideration under
21 CFR 10.33(b). A petitioner shall identify the form of review
requested (hearing or independent advisory committee) and shall submit
with the petition supporting data and information showing that there is
a genuine and substantial issue of material fact for resolution through
administrative review. After reviewing the petition, FDA will decide
whether to grant or deny the petition and will publish a notice of its
decision in the Federal Register. If FDA grants the petition, the
notice will state the issue to be reviewed, the form of review to be
used, the persons who may participate in the review, the time and place
where the review will occur, and other details.
Petitioners may, at any time on or before June 23, 1997, file with
the Dockets Management Branch (address above) two copies of each
petition and supporting data and information, identified with the name
of the device and the docket number found in brackets in the heading of
this document. Received petitions may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under
authority delegated to the Commissioner of Food and Drugs
[[Page 28053]]
(21 CFR 5.10) and redelegated to the Director, Center for Devices and
Radiological Health (21 CFR 5.53).
Dated: April 22, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-13535 Filed 5-21-97; 8:45 am]
BILLING CODE 4160-01-F
