[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Notices]
[Pages 12217-12218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6409]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0051]
Eurexpan Labo; Premarket Approval of ContaClair Multi-
Purpose Solution
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application submitted by the law firm of Akin, Gump,
Strauss, Hauer and Field, as the United States Representative on behalf
of Eurexpan Labo, 41120 Cellettes, France, for premarket approval,
under the Federal Food, Drug, and Cosmetic Act (the act), of
ContaClair Multi-Purpose Solution. FDA's Center for Devices
and Radiological Health (CDRH) notified the applicant, by letter of
June 20, 1996, of the approval of the application.
DATES: Petitions for administrative review by April 14, 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 December 19, 1991, the law firm of Akin,
Gump, Strauss, Hauer and Field, as the United States Representative on
behalf of Eurexpan Labo, 41120 Cellettes, France, submitted to CDRH an
application for premarket approval of ContaClair Multi-
Purpose Solution. The device is a cleaning, rinsing, disinfecting, and
storing solution and is indicated for cleaning, rinsing, disinfecting,
and storing daily and extended wear clear and tinted soft (hydrophilic)
contact lenses.
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
[[Page 12218]]
committee, for review and recommendation because the information in the
PMA substantially duplicates information previously reviewed by this
panel.
On June 20, 1996, 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.
Petitioners may, at any time on or before April 14, 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: January 16, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-6409 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F
