CIBA Vision Corp.; Premarket Approval of Unizyme Enzymatic Cleaner

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M-0126]

CIBA Vision Corp.; Premarket Approval of Unizyme Enzymatic

Cleaner

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 the Federal Food, Drug, and Cosmetic Act (the

act), of Unizyme Enzymatic Cleaner. FDA's Center for Devices and

Radiological Health (CDRH) notified the applicant, by letter of January

31, 1997, of the approval of the application.

DATES: Petitions for administrative review by May 8, 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 August 15, 1996, CIBA Vision Corp.,

Duluth, GA, 30155-1518, submitted to CDRH an application for premarket

approval of Unizyme Enzymatic Cleaner. The device is a periodic cleaner

and is indicated for use with (hydrogen peroxide), lens care systems in

the weekly cleaning of soft (hydrophilic) contact lenses (including

daily wear, extended wear, tinted lenses, and lenses prescribed for

scheduled replacement).

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 premarket approval application (PMA) 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 PMA substantially duplicates information previously

reviewed by this panel. On January 31, 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 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.

[[Page 16863]]

Petitioners may, at any time on or before May 8, 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 (21 CFR 5.10)

and redelegated to the Director, Center for Devices and Radiological

Health (21 CFR 5.53).

Dated: March 4, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 97-8853 Filed 4-7-97; 8:45 am]

BILLING CODE 4160-01-F