Document ID: FDA-2009-D-0386-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability
Posted Date: 2009-09-09T04:00Z

[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Notices]               
[Page 46433-46434]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se09-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0386]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; Establishing the Performance Characteristics of In Vitro 
Diagnostic Devices for the Detection or Detection and Differentiation 
of Human Papillomaviruses; 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availability of the draft guidance entitled ``Establishing the 
Performance Characteristics of In Vitro Diagnostic Devices for the 
Detection or Detection and Differentiation of Human Papillomaviruses.'' 
FDA is issuing this draft guidance to inform industry and agency staff 
of its recommendations for analytical and clinical performance studies 
to support premarket submissions for in vitro diagnostic devices 
intended for the detection or detection and differentiation of human 
papillomaviruses.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 8, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Establishing the Performance 
Characteristics of In Vitro Diagnostic Devices for the Detection or 
Detection and Differentiation of Human Papillomaviruses'' to the 
Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver 
Spring, MD 20993. Send one self-addressed adhesive label to assist that 
office in processing your request, or fax your request to 301-847-8149. 
See the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the 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.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kate Simon, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5552, Silver Spring, MD 20993, 301-796-6204.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document recommends studies that may be used to 
establish the analytical and clinical performance of in vitro 
diagnostic devices (IVDs) for the detection or detection and 
differentiation of human papillomaviruses (HPV) in cervical specimens. 
This guidance is limited to studies intended to establish the 
performance characteristics of in vitro diagnostic HPV devices that are 
used in conjunction with cervical cytology for cervical cancer 
screening. It does not

[[Page 46434]]

address HPV devices that are intended to be used independent of a 
cervical cytology result.
    The one product code established for this HPV DNA detection device 
is code MAQ, class III. The recommendations in this guidance apply to 
HPV diagnostic devices that detect HPV nucleic acid (not only HPV DNA, 
but HPV RNA, as well). Many of the recommendations will also apply to 
HPV detection devices that utilize targets other than HPV nucleic acid 
(such as HPV protein). This guidance therefore may encompass future HPV 
product codes beyond the one listed. Because HPV diagnostic devices are 
postamendment devices, they are automatically classified as class III 
under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(f)(1)).

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, when 
finalized will represent the agency's current thinking on establishing 
the performance characteristics of in vitro diagnostic devices for the 
detection or detection and differentiation of human papillomaviruses. 
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

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Establishing the Performance 
Characteristics of In Vitro Diagnostic Devices for the Detection or 
Detection and Differentiation of Human Papillomaviruses,'' you may 
either send an e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 301-847-8149 
to receive a hard copy. Please use the document number 1699 to identify 
the guidance you are requesting.
    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 at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. These 
collections of information are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
814 have been approved under OMB Control No. 0910-0231; the collections 
of information in 21 CFR part 812 have been approved under OMB Control 
No. 0910-0078; and the collections of information in 21 CFR 809.10 have 
been approved under OMB Control No. 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: August 26, 2009.
Catherine M. Cook,
Associate Director for Regulations and Policy.
[FR Doc. E9-21725 Filed 9-8-09; 8:45 am]

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