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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

 Food and Drug Administration, HHS.

# ACTION:

 Notice.

# 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 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human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 FDA is issuing this draft guidance to inform industry and agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 8, 2009.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                         Submit written requests for single copies of the draft guidance document entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human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                    Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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                           ( print 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]

BILLING CODE 4160-01-S