[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]
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