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

Summary:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.” This guidance document provides industry and Agency staff with recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for thedetection, or detection and differentiation, of human papillomaviruses.

Table of Contents

Dates:

Submit either electronic or written 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 of the 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 20993-0002. 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 electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 20993-0002, (301) 796-6210.

Supplementary information:

I. Background

FDA is issuing this guidance to provide industry and Agency staff with recommendations for studies to establish the performance characteristics of IVDs intended for the detection, or detection and differentiation, of human papillomaviruses. These devices are used in conjunction with cervical cytology to aid in screening for cervical cancer. They include devices that detect a group of human papillomavirus (HPV) genotypes, particularly high risk human papillomaviruses, as well as devices that detect more than one genotype of HPV and further differentiate among them to indicate which genotype(s) of HPV is (are) present.

In the Federal Register of September 9, 2009 (74 FR 46433), FDA announced the availability of the draft guidance. Comments on the draft guidance were due by December 8, 2009. Five comments were received on the guidance document. We reviewed the comments and took their suggestions into consideration in revising this guidance.

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 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 guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. 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 email 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 1740 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. 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 number. 0910-0231; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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: November 22, 2011. Leslie Kux,

Acting Assistant Commissioner for Policy.

References

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