[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9424]
[[Page Unknown]]
[Federal Register: April 19, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0061]
Nissel, Ltd.; Premarket Approval of S-38TM Soft (Polymacon)
Contact Lens
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Nissel, Ltd., Hertfordshire, England,
for premarket approval, under section 515 of the Federal Food, Drug,
and Cosmetic Act (the act), of the S-38TM Soft (polymacon) Contact
Lens. The device is to be manufactured under an agreement with Allergan
Optical, Irvine, CA, and OSI Corp., South San Francisco, CA, which have
authorized Nissel, Ltd., to incorporate information contained in the
approved premarket approval application and related supplements for the
Hydron (polymacon) Hydrophilic Contact Lenses. FDA's Center
for Devices and Radiological Health (CDRH) notified the applicant, by
letter of November 26, 1993, of the approval of the application.
DATES: Petitions for administrative review by May 19, 1994.
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, 1390
Piccard Dr., Rockville, MD 20850, 301-594-2080.
SUPPLEMENTARY INFORMATION: On July 16, 1992, Nissel, Ltd.,
Hertfordshire, England, submitted to CDRH an application for premarket
approval of the S-38TM Soft (polymacon) Contact Lens. The S-
38TM Soft (polymacon) Contact Lens is indicated for daily wear for
the correction of visual acuity in aphakic and not-aphakic persons with
nondiseased eyes that are myopic or hyperopic. The lens may be worn by
persons who may exhibit astigmatism of 1.50 diopters or less that does
not interfere with visual acuity. In addition, the lens is to be
disinfected using either a heat or chemical lens care system. The
application includes authorization from Allergan Optical, Irvine, CA
92713-9534, and OSI Corp., South San Francisco, CA 94080, to
incorporate information contained in the approved premarket approval
application and related supplements for Hydron (polymacon)
Hydrophilic Contact Lenses. 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
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 November 26, 1993, CDRH approved the application by a letter to the
applicant from the Acting 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 S-38TM Soft (Polymacon) Contact Lens
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 (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 May 19, 1994, 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 Center for Devices and Radiological Health (21
CFR 5.53).
Dated: April 5, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-9424 Filed 4-18-94; 8:45 am]
BILLING CODE 4160-01-F
