[Federal Register Volume 63, Number 1 (Friday, January 2, 1998)]
[Notices]
[Pages 88-89]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-34157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0519]
Vitrophage, Inc.; Premarket Approval of VITREON
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 submitted by Vitrophage, Inc., Lyons, IL,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of VITREON . After reviewing the recommendation of
the Ophthalmic Devices Panel, FDA's Center for Devices and Radiological
Health (CDRH) notified the applicant, by letter of September 30, 1997,
of the approval of the application.
DATES: Petitions for administrative review by February 2, 1998.
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 December 6, 1991, Vitrophage, Inc.,
Lyons, IL 60534, submitted to CDRH an application for premarket
approval of VITREON. The device is a purified perfluorocarbon
liquid and is indicated for use as an intraoperative surgical aid
during vitreoretinal surgery in patients with primary and recurrent
complicated retinal detachments. Complicated cases include giant
retinal tear or retinal dialysis, proliferative vitreoretinopathy,
proliferative diabetic retinopathy, tractional retinal detachments, and
blunt or penetrating ocular trauma.
On October 19, 1995, the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On September 30, 1997, 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, 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 the 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 February 2, 1998, file
with the Dockets Management Branch (address above) two copies of each
petition and supporting data and information,
[[Page 89]]
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: December 1, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-34157 Filed 12-31-97; 8:45 am]
BILLING CODE 4160-01-F
