[Federal Register Volume 69, Number 52 (Wednesday, March 17, 2004)]
[Notices]
[Pages 12701-12702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5979]



[[Page 12701]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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Draft Guidance for Industry and Food and Drug Administration 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.

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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availability of the draft guidance entitled ``Class II Special Controls 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 This draft 
guidance document describes a means by which external penile rigidity 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 This draft guidance is neither final nor is 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DATES:  Submit written or electronic comments on this draft guidance by 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diskette of the draft guidance document entitled ``Class II Special 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INFORMATION section for information on electronic access to the draft 
guidance.
    Submit written comments concerning this draft guidance to the 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://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

    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 
device.

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://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 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://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.


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    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]
BILLING CODE 4160-01-S