[Federal Register: March 17, 2004 (Volume 69, Number 52)]
[Page 12701-12702]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 12701]]



Food and Drug Administration

[Docket No. 2004D-0071]

Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: External Penile
Rigidity Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: External Penile Rigidity Devices.'' This draft
guidance document describes a means by which external penile rigidity
devices may comply with the requirement of special controls for class
II devices. Elsewhere in this issue of the Federal Register, FDA is
issuing a proposed rule to classify external penile rigidity devices
into class II with special controls. The proposed rule also announces
FDA's intent to exempt external penile rigidity devices from premarket
notification requirements. This draft guidance is neither final nor is
it in effect at this time.

DATES:  Submit written or electronic comments on this draft guidance by
June 15, 2004.

ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: External Penile Rigidity Devices'' to the
Division of Small Manufacturers, International, and Consumer Assistance
(HFZ-220), Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to (301) 443-8818. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the draft
    Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments

with the docket number found in brackets in the heading of this

FOR FURTHER INFORMATION CONTACT: Janine Morris, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, (301) 594-2194.


I. Background

    At a public meeting held on August 7, 1997, the Gastroenterology-
Urology Advisory Panel (the Panel) recommended that external penile
rigidity devices be classified into class II. The Panel identified
special controls as labeling recommendations with specific information
for each of the devices. This draft guidance document supports the
classification of external penile rigidity devices into class II. The
guidance document will serve as the special control for these devices,
if the proposed rule becomes final. Following the effective date of a
final rule classifying the devices, a manufacturer intending to market
external penile rigidity devices, who addresses the issues covered in
the special control guidance before introducing its device into
commercial distribution in the United States, will be able to market
its device without being subject to the premarket notification
requirements of section 510(k) of the Federal Food, Drug and Cosmetic
Act. However, the firm need only show that its device meets the
recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness. FDA may not
implement the guidance until the agency completes notice and comment
rulemaking to classify the devices.
    The draft guidance identifies the risks to health and serves as a
special control that, when followed and combined with the general
controls, addresses the risks associated with this type of generic

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the agency's current thinking on 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 requirements of the
applicable statute and regulations.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: External
Penile Rigidity Devices'' by fax machine, call the CDRH Facts-On-Demand
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone.
Press 1 to enter the system. At the second voice prompt, press 1 to
order a document. Enter the document number (1231) followed by the
pound sign ([numsign]). Follow the remaining voice prompts to complete
your request.
    Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. CDRH maintains an entry on the
Internet for easy access to information including text, graphics, and
files that may be downloaded to a personal computer with Internet
access. Updated on a regular basis, the CDRH home page includes device
safety alerts, Federal Register reprints, information on premarket
submissions (including lists of approved applications and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. The CDRH Web site may be
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.

guidance.html. Guidance documents are also available on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520) (the PRA).
The labeling provisions addressed in the draft guidance have been
approved by OMB under the PRA under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Submit two paper copies of any mailed

comments, except that individuals may submit one paper copy. Comments
are to identified with the docket number found in brackets in the
heading of this document. Comments received may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 12702]]

    Dated: March 4, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices
and Radiological Health.
[FR Doc. 04-5979 Filed 3-16-04; 8:45 am]