Document ID: FDA-2009-D-0386-0011
Agency: fda
Document Type: Notice
Title: Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for the Detection or Detection and Differentiation of Human
Papillomaviruses; Draft Guidance for Industry and Food and Drug
Administration Staff: Availability
Posted Date: 2015-08-14T04:00Z

[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48879-48880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19983]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Establishing the Performance Characteristics of In Vitro 
Diagnostic Devices for the Detection or Detection and Differentiation 
of Human Papillomaviruses; Draft Guidance for Industry and Food and 
Drug Administration Staff: Availability

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availability of the draft guidance entitled ``Establishing the 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.'' 
This draft guidance provides recommendations to facilitate study 
designs to establish the performance characteristics of in vitro 
diagnostic devices (IVDs) intended for the detection, or detection and 
differentiation, of human papillomaviruses (HPVs). This draft guidance 
is not final nor is it in effect at this time.

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 of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance November 12, 2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 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 Office of the Center Director, Guidance and 
Policy Development, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.
    Submit electronic comments on the draft 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: Natalia Comella, Center for Devices 
and Radiological Health, Food and Drug Administration, New Hampshire 
Ave., Bldg. 66, Rm. 4536, Silver Spring, MD 20993-0002, 301-796-6226, 
Natalia.Comella@fda.hhs.gov, or Marina V. Kondratovich, Center for 
Devices and Radiological Health, Food and Drug Administration, New 
Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301-
796-6036, Marina.Kondratovich@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    This draft guidance provides recommendations to facilitate study 
designs to establish the performance characteristics of IVDs intended 
for the detection, or detection and differentiation, of HPVs. These 
devices are used either in conjunction with cervical cytology to aid in 
screening for cervical cancer or as first-line primary cervical cancer 
screening devices. These devices include those that detect a group of 
HPV genotypes, particularly high risk HPVs, as well as devices that 
detect more than one genotype of HPV and further differentiate among 
them to indicate which genotype of HPV is present or which genotypes of 
HPV are present.
    When finalized, this draft guidance is expected to provide detailed 
information on the types of studies the FDA recommends to support a 
premarket application for these devices. This draft guidance 
specifically addresses devices that qualitatively detect HPV nucleic 
acid from cervical specimens, but many of the recommendations will also 
be applicable to devices that detect HPV proteins. The draft 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 cancer screening or as first-
line primary cervical cancer screening devices. This draft guidance 
does not address HPV testing from non-cervical specimens such as 
pharyngeal, vaginal, penile, or anal specimens, or testing for 
susceptibility to HPV infection. It does not address quantitative or 
semi-quantitative assays for HPV.

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 current thinking of FDA on evaluating the 
performance characteristics of IVDs intended for the detection, or 
detection and differentiation, of HPVs. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it 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 downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons

[[Page 48880]]

unable to download an electronic copy of ``Establishing the Performance 
Characteristics of In Vitro Diagnostic Devices for the Detection or 
Detection and Differentiation of Human Papillomaviruses'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1740 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 parts 801 and 809 have been 
approved under OMB control number 0910-0485; and the collections of 
information in the guidance document entitled ``Informed Consent For In 
Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are 
Not Individually Identifiable'' have been approved under OMB control 
number 0910-0582.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19983 Filed 8-13-15; 8:45 am]
BILLING CODE 4164-01-P