[Federal Register Volume 62, Number 130 (Tuesday, July 8, 1997)]
[Notices]
[Pages 36555-36556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17676]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0272]


Biocompatibles, Inc.; Premarket Approval of Soft-55 EW Aphakic 
(vifilcon A) Soft (Hydrophilic) Contact Lenses 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

[[Page 36556]]

approval of the application by Biocompatibles, Inc., Norfolk, VA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of Soft-55 EW Aphakic (vifilcon A) Soft (Hydrophilic) Contact 
Lenses for Extended Wear. The device is to be manufactured under an 
agreement with Ciba Vision Corp., Duluth, GA, which has authorized 
Biocompatibles, Inc., to incorporate information contained in its 
approved premarket approval applications (PMA's) for the Softcon E.W. 
(vifilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear. FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of April 17, 1997, of the approval of the 
application.

DATES: Petitions for administrative review by August 7, 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 November 12, 1996, Biocompatibles, Inc., 
Norfolk, VA 23507, submitted to CDRH an application for premarket 
approval of Soft-55 EW Aphakic (vifilcon A) Soft (Hydrophilic) Contact 
Lenses for Extended Wear. The device is a soft (hydrophilic) contact 
lens and is indicated for extended wear from 1 to 7 days between 
removals for cleaning and disinfection as recommended by the eye care 
practitioner. The lenses are indicated for the correction of visual 
acuity in aphakic persons (after cataract surgery) that are myopic or 
hyperopic. Soft-55 EW Aphakic Lenses may be worn by persons who may 
exhibit astigmatism of 2.00 diopters or less that does not interfere 
with visual acuity. The application includes authorization from Ciba 
Vision Corp., Duluth, GA 30136-1518, to incorporate information 
contained in its approved PMA's for Softcon E.W. (vifilcon A) Soft 
(Hydrophilic) Contact Lenses for Extended Wear.
     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 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 April 17, 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.
     The labeling of the Soft-55 EW Aphakic (vifilcon A) Soft 
(Hydrophilic) Contact Lenses for Extended Wear states that the lens is 
to be used only with certain solutions for disinfection and other 
purposes. The restrictive labeling informs new users that they must 
avoid using certain products, such as solutions intended for use with 
hard contact lenses only.

 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 August 7, 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: June 17, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-17676 Filed 7-7-97; 8:45 am]
BILLING CODE 4160-01-F