[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25518]
[[Page Unknown]]
[Federal Register: October 14, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0339]
IOLAB Corp.; Premarket Approval of the Models LI30U, LI32U, and
LI41U SOFLEXTM Ultraviolet-Absorbing Silicone Posterior Chamber
Intraocular Lenses
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 IOLAB Corp., Claremont, CA, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the Models LI30U, LI32U, and LI41U SOFLEXTM ultraviolet-
absorbing silicone posterior chamber intraocular lenses. After
addressing the concerns of the Ophthalmic Devices Panel, FDA's Center
for Devices and Radiological Health (CDRH) notified the applicant, by
letter of September 2, 1994, of the approval of the application.
DATES: Petitions for administrative review by November 14, 1994.
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, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Donna L. Rogers, Center for Devices
and Radiological Health (HFZ-463), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-2053.
SUPPLEMENTARY INFORMATION: On October 8, 1991, IOLAB Corp., Claremont,
CA 91711, submitted to CDRH an application for premarket approval of
the Models LI30U, LI32U, and LI41U SOFLEXTM ultraviolet-absorbing
silicone posterior chamber intraocular lenses. The devices are
intraocular implants and are indicated for primary implantation for the
visual correction of aphakia in persons 60 years of age or older where
a cataractous lens has been removed by extracapsular cataract
extraction. The lenses are intended to be placed in either the ciliary
sulcus or capsular bag.
On May 20, 1993, the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended disapproval of the application. The concerns of the panel
have been adequately addressed by IOLAB Corp. in subsequent submissions
to FDA. On September 2, 1994, 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.
Opportunity for Administrative Review
Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any
interested person to petition, under section 515(g) of the act (21
U.S.C. 360e(g)), for administrative review of CDRH's decision to
approve this application. A petitioner may request either a formal
hearing under part 12 (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
Sec. 10.33(b) (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 November 14, 1994, 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 (21 CFR 5.10)
and redelegated to the Director, Center for Devices and Radiological
Health (21 CFR 5.53).
Dated: October 3, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-25518 Filed 10-13-94; 8:45 am]
BILLING CODE 4160-01-F
