Document ID: FDA-2009-D-0386-0009
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Staff; Availability: Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection, etc., of Human Papillomaviruses
Posted Date: 2011-11-28T05:00Z

[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72951-72952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30552]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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.

-----------------------------------------------------------------------

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 the

[[Page 72952]]

detection, or detection and differentiation, of human papillomaviruses.

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.
[FR Doc. 2011-30552 Filed 11-25-11; 8:45 am]
BILLING CODE 4160-01-P