Document ID: FDA-2009-D-0386-0016
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; Guidance for Industry and Food and Drug  Administration Staff; Availability
Posted Date: 2017-09-15T04:00Z

[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43386-43387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19612]

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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; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 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 guidance 
replaces a previously issued final guidance entitled ``Establishing the 
Performance Characteristics of In Vitro Diagnostic Devices for the 
Detection, or Detection and Differentiation of Human 
Papillomaviruses,'' dated November 28, 2011.

DATES: The announcement of the guidance is published in the Federal 
Register on September 15, 2017.

ADDRESSES: You may submit either written or electronic comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0386 for ``Establishing the Performance Characteristics of 
In Vitro Diagnostic Devices for the Detection or Detection and 
Differentiation of Human Papillomaviruses.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management

[[Page 43387]]

Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    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 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.

FOR FURTHER INFORMATION CONTACT: Natalia Comella, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4536, Silver Spring, MD 20993-0002, 301-
796-6226, Natalia.Comella@fda.hhs.gov or Marina 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 guidance provides recommendations to facilitate study designs 
to establish the performance characteristics of IVDs intended for the 
detection, or detection and differentiation, of high risk HPV 
genotypes. 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. This guidance provides 
recommendations for HPV devices 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 genotypes of HPV are present. This guidance is expected to 
provide detailed information on the types of studies FDA recommends to 
support a premarket application for these devices.
    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 cancer screening or as 
first-line primary cervical cancer screening devices. While this 
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. This 
guidance provides FDA's recommendations for three types of cervical 
cancer screening modalities, however, FDA does not make any assertions 
on which method of screening is preferred. This 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.
    In the Federal Register of August 14, 2015 (80 FR 48879), FDA 
announced the availability of the draft of this guidance and interested 
persons were invited to comment by November 12, 2015. FDA has 
considered all of the public comments received in finalizing this 
guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
current thinking of FDA on ``Establishing the Performance 
Characteristics of In Vitro Diagnostic Devices for the Detection or 
Detection and Differentiation of Human Papillomaviruses.'' 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 statutes and regulations. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 https://www.regulations.gov. Persons 
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 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; 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; and the collections of information in the guidance 
document entitled ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' have been approved under OMB control number 
0910-0756.

    Dated: September 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19612 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P