[Federal Register Volume 60, Number 18 (Friday, January 27, 1995)]
[Notices]
[Pages 5431-5432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2112]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94M-0414]
Pilkington Barnes Hind USA; Premarket Approval of Precision
UVTM (Vasurfilcon A) Hydrophilic Contact Lens for Extended Wear
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 Pilkington Barnes Hind, USA, Sunnyvale,
CA, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of the Precision UVTM (vasurfilcon A) Hydrophilic
Contact Lens for extended wear. The device is to be manufactured under
an agreement with Allergan Medical Optics, Irvine, CA, which has
authorized Pilkington Barnes Hind, USA to incorporate information
contained in its approved premarket approval application (PMA) for the
lidofilcon B nonultraviolet absorbing lens material and all related
supplements that lead to the approval of the vasurfilcon A material.
FDA's Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of September 30, 1994, of the approval of the
application.
DATES: Petitions for administrative review by February 27, 1995.
[[Page 5432]] 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, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1744.
SUPPLEMENTARY INFORMATION: On August 12, 1994, Pilkington Barnes Hind,
USA, Sunnyvale, CA 94086-5200, submitted to CDRH an application for
premarket approval of the Precision UVTM (vasurfilcon A)
Hydrophilic Contact Lens for extended wear. The device is a spherical
soft (hydrophilic) contact lens and is indicated for nonaphakic daily
or extended wear from 1 to 7 days between removals for cleaning,
rinsing, and disinfecting, as recommended by the eye care practitioner.
Candidates to use the Precision UVTM Hydrophilic Contact Lens
include persons who are nearsighted (myopic) and farsighted (hyperopic)
and who may have astigmatism of 2.0 diopters or less that does not
interfere with visual acuity.
The application includes authorization from Allergan Medical
Optics, Irvine, CA, 92713-9534, to incorporate information contained in
its approved PMA for lidofilcon B nonabsorbing ultraviolet lens
material and all related supplements that lead to the approval of the
vasurfilcon A material.
In the Federal Register of March 4, 1994 (59 FR 10397), CDRH
published an order which reclassified daily wear soft and daily wear
nonhydrophilic plastic contact lenses from class III (premarket
approval) into class II (special controls). CDRH notes that the daily
wear indication for this lens has received marketing clearance as a
class II device through the premarket notification (510(k)) procedures.
In accordance with the provisions of section 515(c)(2) of the act
as amended by the Safe Medical Devices Act of 1990, this PMA was not
referred to the Ophthalmic Devices Panel, an FDA advisory panel, for
review and recommendation because the information in the PMA
substantially duplicates information previously reviewed by this panel.
On September 30, 1994, 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 (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 February 27, 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: January 11, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-2112 Filed 1-26-95; 8:45 am]
BILLING CODE 4160-01-F