[Federal Register Volume 63, Number 1 (Friday, January 2, 1998)]
[Notices]
[Pages 87-88]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-34156]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0521]
Richard-James, Inc.; Premarket Approval of SILIKON 1000-Silicone
Oil
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 Richard-James, Inc., Peabody,
MA, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of the SILIKON 1000-Silicone Oil. 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 25, 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, 301-594-2018.
SUPPLEMENTARY INFORMATION: On February 22, 1995, Richard-James, Inc.,
Peabody, MA 01960, submitted to CDRH an application for premarket
approval of the SILIKON 1000-Silicone Oil. The device is an intraocular
fluid and is indicated for use as a prolonged retinal tamponade in
selected cases of complicated retinal detachments where other
interventions are not appropriate
[[Page 88]]
for patient management. Complicated retinal detachments or recurrent
retinal detachments occur most commonly in eyes with proliferative
vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR),
cytomegalovirus (CMV) retinitis, giant tears, and following perforating
injuries. SILIKON 1000 is also indicated for primary use in detachments
due to acquired immune deficiency syndrome (AIDS) related CMV retinitis
and other viral infections affecting the retina.
On January 13, 1997, the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On September 25, 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, 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. 97-34156 Filed 12-31-97; 8:45 am]
BILLING CODE 4160-01-F
