current thinking on external penile rigidity devices by the Food & Drug Adminstration

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My "Human Resource Department Manager" will not approve of my noting the =
absurd idea of the Food and Drug Administration publishing the =
following, but she is still in the hospital tonight and I just could not =
resist the temptation.  So, if my joking attitude offends you, please =
forgive me ahead of time, have a spoon of Chocolate and read on........

Sonny

[Federal Register: January 2, 1998 (Volume 63, Number 1)][Notices]       =


-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0514]
=20
CDRH Interim Regulatory Policy for External Penile Rigidity=20
Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is making available a=20
policy from its Center for Devices and Radiological Health (CDRH)=20
entitled ``CDRH Interim Regulatory Policy for External Penile Rigidity=20
Devices.'' The document outlines several changes in how FDA regulates=20
external penile rigidity devices including constriction rings, vacuum=20
pumps, and penile splints.

DATES: Written comments concerning this guidance may be submitted at=20
any time.

ADDRESSES: Written comments concerning this guidance must be submitted=20
to the contact person. Comments should be identified with the docket=20
number found in brackets in the heading of this document. See the=20
SUPPLEMENTARY INFORMATION section for electronic access to the policy.=20

Submit written requests for single copies of the ``CDRH Interim=20
Regulatory Policy for External Penile Rigidity Implants'' to the=20
Division of Small Manufacturers Assistance, Center for Devices and=20
Radiological Health (HFZ-220), Food and Drug Administration, 1350=20
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive=20
labels to assist that office in processing your request, or fax your=20
request to 301-443-8818.

FOR FURTHER INFORMATION CONTACT: Donald St. Pierre, Center for Devices=20
and Radiological Health (HFZ-450), Food and Drug Administration, 9200=20
Corporate Blvd., Rockville, MD 20850, 301-594-2194.


SUPPLEMENTARY INFORMATION:
I. Background
    External penile rigidity devices are unclassified medical devices=20
designed to promote or maintain sufficient penile rigidity for sexual=20
intercourse. This document clarifies when premarket review is required=20
for new external penile rigidity devices using a uniform approach. The=20
new policy also allows manufacturers the option of marketing external=20
penile rigidity devices as prescription and/or over the counter (OTC)=20
devices.

    This guidance document represents the agency's current thinking on=20
regulation of external penile rigidity devices. It does not create or=20
confer any rights for or on any person and does not operate to bind FDA=20
or the public. An alternative approach may be used if such approach=20
satisfies the applicable statute, regulations, or both. The agency has=20
adopted Good Guidance Practices (GGP's), which set forth the agency's=20
policies and procedures for the development, issuance, and use of=20
guidance documents (61 FR 8961, February 27, 1997). This guidance is=20
issued as Level 2 guidance consistent with GGP's.

II. Electronic Access <for External Penile Rigidity Implants?>=20
    The Center for Devices and Radiological=20
Health (CDRH) maintains an entry on the World Wide Web for easy access=20
to information including text, graphics, and files that may be=20
downloaded to a personal computer with access to the Web. Updated on a=20
regular basis, the CDRH Home Page includes the CDRH Interim Regulatory=20
Policy for External Penile Rigidity Devices, device safety alerts,=20
Federal Register reprints, information on premarket submissions=20
(including lists of approved applications and manufacturers'=20
addresses), small manufacturers' assistance, information on video=20
conferencing and electronic submissions, mammography matters, and other=20
device-oriented information. The CDRH home page may be accessed at=20
http://www.fda.gov/cdrh. The CDRH Interim Regulatory Policy for=20
External Penile Rigidity Devices will be available at http://
www.fda.gov/cdrh/ode/expenrig.html.

    III. Comments
    Interested persons may at any time submit written comments on the=20
guidance document to the contact person. Comments will be considered in=20
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=20
Radiological Health.
[FR Doc. 97-34158 Filed 12-31-97; 8:45 am]




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