[Federal Register Volume 60, Number 71 (Thursday, April 13, 1995)]
[Notices]
[Pages 18845-18846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9181]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0068]
Polymer Technology Division of Wilmington Partners L. P.;
Premarket Approval of BOSTON Advance Comfort Formula
Conditioning Solution
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 Polymer Technology Division of
Wilmington Partners L. P., Wilmington, MA, for
[[Page 18846]]
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the BOSTON Advance Comfort Formula Conditioning
Solution. FDA's Center for Devices and Radiological Health (CDRH)
notified the applicant, by letter of March 1, 1995, of the approval of
the application.
DATES: Petitions for administrative review by May 15, 1995.
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: David M. Whipple, 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 29, 1992, Polymer Technology
Division of Wilmington Partners L. P., Wilmington, MA 01887, submitted
to CDRH an application for premarket approval of the BOSTON
Advance Comfort Formula Conditioning Solution. The device is
a disinfecting and soaking solution and is indicated for disinfecting
and soaking fluoro silicone acrylate and silicone acrylate rigid gas
permeable 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 committee, for review and recommendation because the
information in the PMA substantially duplicates information previously
reviewed by this panel. On March 1, 1995, 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 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 15, 1995, 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 24, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-9181 Filed 4-12-95; 8:45 am]
BILLING CODE 4160-01-F
