[Federal Register Volume 59, Number 74 (Monday, April 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9190]
[[Page Unknown]]
[Federal Register: April 18, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0037]
CIBA Vision Corp.; Premarket Approval of the NDS System
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 CIBA Vision Corp., Duluth, GA, for
premarket approval, under section 515 of the Federal Food, Drug, and
Cosmetic Act (the act), of the NDS System. After reviewing the
recommendation of the Ophthalmic Devices Panel, FDA's Center for
Devices and Radiological Health (CDRH) notified the applicant by letter
of January 10, 1994, of the approval of the application.
DATES: Petitions for administrative review by May 18, 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: James F. Saviola, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1744.
SUPPLEMENTARY INFORMATION: On April 9, 1990, CIBA Vision Corp., Duluth,
GA 30136-1518, submitted to CDRH an application for premarket approval
of the NDS System. The system consists of the NDS Starting Solution and
the NDS Finishing Solution. The NDS System is indicated for the
cleaning, disinfecting, rinsing, soaking and storage of soft
(hydrophilic) contact lenses. In addition, the NDS Finishing Solution
is indicated to dissolve enzyme tablets.
On April 18, 1991, the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On January 10, 1994, CDRH
approved the application by a letter to the applicant from the Acting
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 Docket 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 May 18, 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 Center for Devices and Radiological Health (21
CFR 5.53).
Dated: March 10, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-9190 Filed 4-15-94; 8:45 am]
BILLING CODE 4160-01-F