[Federal Register Volume 60, Number 110 (Thursday, June 8, 1995)]
[Notices]
[Pages 30310-30311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14059]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0119]


Chartex International plc; Premarket Approval of 
Femidom Female Condom

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 submitted by Chartex International plc, 
London, U.K., for premarket approval, under the Federal Food, Drug, and 
Cosmetic Act (the act), of the Femidom Female Condom. The 
device is to be manufactured under an agreement with Wisconsin 
Pharmacal Co., Inc., Jackson, WI, which has authorized Chartex 
International plc to incorporate information contained in its approved 
premarket approval application for the RealityTM Female Condom 
(P910064). FDA's Center for Devices and Radiological Health (CDRH) 
notified the applicant, by letter of April 14, 1995, of the approval of 
the application.

DATES: Petitions for administrative review by July 10, 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: Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.
SUPPLEMENTARY INFORMATION: On September 30, 1994, Chartex International 
plc, London, U.K., submitted to CDRH an application for premarket 
approval of the Femidom Female Condom. The device is an 
intravaginal barrier device and is indicated for use to help prevent 
pregnancy and sexually transmitted diseases (STD's), including the 
human immunodeficiency virus (HIV) infection during vaginal 
intercourse. The application includes authorization from Wisconsin 
Pharmacal Co., Inc., Jackson, WI, 53037, to incorporate information 
contained in its approved premarket approval application for the 
RealityTM Female Condom (P910064). 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 
Obstetrics and Gynecology 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 April 14, 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 
[[Page 30311]] 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 July 10, 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: May 26, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-14059 Filed 6-7-95; 8:45 am]
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