[Federal Register Volume 69, Number 248 (Tuesday, December 28, 2004)]
[Notices]
[Pages 77757-77758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0071]


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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: External Penile Rigidity Devices.'' This 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 
publishing a final rule to classify this device type into class II 
(special controls) and to exempt it from premarket notification 
requirements.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the 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 
guidance.
    Submit written comments concerning this 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://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 17, 2004 (69 FR 12701), FDA 
announced the availability of a draft of this guidance document and 
invited interested persons to comment on it by June 15, 2004. FDA 
received no comments on the proposed guidance and classification rule. 
The guidance document provides a means by which external penile 
rigidity devices may comply with the requirement of special controls 
for class II devices. Following the effective date of the final 
classification rule, manufacturers will need to address the issues 
covered in this special control guidance. However, the manufacturer 
need only show that its device meets the recommendations of the 
guidance or in some other way provides equivalent assurances of safety 
and effectiveness.
    Also in the Federal Register of March 17, 2004 (69 FR 12598), FDA 
proposed to classify external penile rigidity devices into class II 
with this guidance document as the special control. Elsewhere in this 
issue of the Federal Register, FDA is publishing a final rule to 
classify external penile rigidity devices into class II (special 
controls) and exempt the devices from premarket notification 
requirements.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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, 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 
(). Follow the

[[Page 77758]]

remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the 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://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This 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 quality 
system regulation provisions addressed in the guidance have been 
approved by OMB under OMB control number 0910-0773. The labeling 
provisions addressed in the guidance have been approved by OMB 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 or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 15, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-28255 Filed 12-27-04; 8:45 am]
BILLING CODE 4160-01-S