[Federal Register Volume 63, Number 1 (Friday, January 2, 1998)]
[Notices]
[Page 89]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-34158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0514]


CDRH Interim Regulatory Policy for External Penile Rigidity 
Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is making available a 
policy from its Center for Devices and Radiological Health (CDRH) 
entitled ``CDRH Interim Regulatory Policy for External Penile Rigidity 
Devices.'' The document outlines several changes in how FDA regulates 
external penile rigidity devices including constriction rings, vacuum 
pumps, and penile splints.

DATES: Written comments concerning this guidance may be submitted at 
any time.

ADDRESSES: Written comments concerning this guidance must be submitted 
to the contact person. Comments should be identified with the docket 
number found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the policy. 
Submit written requests for single copies of the ``CDRH Interim 
Regulatory Policy for External Penile Rigidity Implants'' to the 
Division of Small Manufacturers Assistance, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818.

FOR FURTHER INFORMATION CONTACT: Donald St. Pierre, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION:

I. Background

    External penile rigidity devices are unclassified medical devices 
designed to promote or maintain sufficient penile rigidity for sexual 
intercourse. This document clarifies when premarket review is required 
for new external penile rigidity devices using a uniform approach. The 
new policy also allows manufacturers the option of marketing external 
penile rigidity devices as prescription and/or over the counter (OTC) 
devices.
    This guidance document represents the agency's current thinking on 
regulation of external penile rigidity devices. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the applicable statute, regulations, or both. The agency has 
adopted Good Guidance Practices (GGP's), which set forth the agency's 
policies and procedures for the development, issuance, and use of 
guidance documents (61 FR 8961, February 27, 1997). This guidance is 
issued as Level 2 guidance consistent with GGP's.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so 
using the World Wide Web (WWW). The Center for Devices and Radiological 
Health (CDRH) maintains an entry on the World Wide Web for easy access 
to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Web. Updated on a 
regular basis, the CDRH Home Page includes the CDRH Interim Regulatory 
Policy for External Penile Rigidity Devices, device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturers' assistance, information on video 
conferencing and electronic submissions, mammography matters, and other 
device-oriented information. The CDRH home page may be accessed at 
http://www.fda.gov/cdrh. The CDRH Interim Regulatory Policy for 
External Penile Rigidity Devices will be available at <a href="http://
www.fda.gov/cdrh/ode/expenrig.html">http://
www.fda.gov/cdrh/ode/expenrig.html</a>.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general 
information, or arrow down for specific topics.

III. Comments

    Interested persons may at any time submit written comments on the 
guidance document to the contact person. Comments will be considered in 
determining whether to revise or revoke the guidance document.

    Dated: December 1, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-34158 Filed 12-31-97; 8:45 am]
BILLING CODE 4160-01-F