82 FR 43386 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 178 (September 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 178 (September 15, 2017)
| Page Range | 43386-43387 | |
| FR Document | 2017-19612 |
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)] [Notices] [Pages 43386-43387] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19612] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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, [email protected] 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, [email protected]. 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 [email protected] 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
![43386 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
reconsideration of an FDA action under applicant; in these cases, the 30-day following is a list of PMAs approved by
§ 10.33(b) (21 CFR 10.33(b)) for notices period will begin when the applicant is CBER for which safety and effectiveness
announcing approval of a PMA begins notified by FDA in writing of its summaries were placed on the internet
on the day the notice is placed on the decision. from October 1, 2016, through June 30,
internet. Section 10.33(b) provides that The regulations (21 CFR 814.44(d) 2017. There were no denial actions
FDA may, for good cause, extend this and 814.45(d)) provide that FDA during this period. The list provides the
30-day period. Reconsideration of a publish a quarterly list of available manufacturer’s name, the product’s
denial or withdrawal of approval of a safety and effectiveness summaries of generic name or the trade name, and the
PMA may be sought only by the PMA approvals and denials that were approval date.
announced during that quarter. The
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2016, THROUGH JUNE 30, 2017
PMA No./Docket No. Applicant Trade name Approval date
BP150318, FDA–2016–M–4529 Hologic, Inc ............................... Aptima HIV-1 Quant Assay .................... December 22, 2016.
BP160050, FDA–2017–M–3899 Roche Diagnostics .................... Elecsys HIV Combi-PT .......................... June 21, 2017.
II. Electronic Access replaces a previously issued final Written/Paper Submissions
Persons with access to the internet guidance entitled ‘‘Establishing the Submit written/paper submissions as
may obtain the documents at https:// Performance Characteristics of In Vitro follows:
www.fda.gov/BiologicsBloodVaccines/ Diagnostic Devices for the Detection, or • Mail/Hand delivery/Courier (for
BloodBloodProducts/ Detection and Differentiation of Human written/paper submissions): Dockets
ApprovedProducts/ Papillomaviruses,’’ dated November 28, Management Staff (HFA–305), Food and
PremarketApprovalsPMAs/default.htm. 2011. Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Dated: September 11, 2017. DATES: The announcement of the
• For written/paper comments
Anna K. Abram, guidance is published in the Federal submitted to the Dockets Management
Deputy Commissioner for Policy, Planning, Register on September 15, 2017. Staff, FDA will post your comment, as
Legislation, and Analysis. well as any attachments, except for
ADDRESSES: You may submit either
[FR Doc. 2017–19607 Filed 9–14–17; 8:45 am] written or electronic comments on information submitted, marked and
BILLING CODE 4164–01–P Agency guidances at any time as identified, as confidential, if submitted
follows: as detailed in ‘‘Instructions.’’
Instructions: All submissions received
DEPARTMENT OF HEALTH AND Electronic Submissions must include the Docket No. FDA–
HUMAN SERVICES 2009–D–0386 for ‘‘Establishing the
Submit electronic comments in the Performance Characteristics of In Vitro
Food and Drug Administration following way: Diagnostic Devices for the Detection or
[Docket No. FDA–2009–D–0386] • Federal eRulemaking Portal: Detection and Differentiation of Human
https://www.regulations.gov. Follow the Papillomaviruses.’’ Received comments
Establishing the Performance instructions for submitting comments. will be placed in the docket and, except
Characteristics of In Vitro Diagnostic Comments submitted electronically, for those submitted as ‘‘Confidential
Devices for the Detection or Detection including attachments, to https:// Submissions,’’ publicly viewable at
and Differentiation of Human www.regulations.gov will be posted to https://www.regulations.gov or at the
Papillomaviruses; Guidance for the docket unchanged. Because your Dockets Management Staff between 9
Industry and Food and Drug comment will be made public, you are a.m. and 4 p.m., Monday through
Administration Staff; Availability solely responsible for ensuring that your Friday.
comment does not include any • Confidential Submissions—To
AGENCY: Food and Drug Administration, confidential information that you or a submit a comment with confidential
HHS. information that you do not wish to be
third party may not wish to be posted,
ACTION: Notice of availability. such as medical information, your or made publicly available, submit your
anyone else’s Social Security number, or comments only as a written/paper
SUMMARY: The Food and Drug submission. You should submit two
Administration (FDA or Agency) is confidential business information, such
copies total. One copy will include the
announcing the availability of the as a manufacturing process. Please note
information you claim to be confidential
guidance entitled ‘‘Establishing the that if you include your name, contact
with a heading or cover note that states
Performance Characteristics of In Vitro information, or other information that
‘‘THIS DOCUMENT CONTAINS
Diagnostic Devices for the Detection or identifies you in the body of your
CONFIDENTIAL INFORMATION.’’ The
Detection and Differentiation of Human comments, that information will be
Agency will review this copy, including
Papillomaviruses.’’ This guidance posted on https://www.regulations.gov. the claimed confidential information, in
mstockstill on DSK30JT082PROD with NOTICES
provides recommendations to facilitate • If you want to submit a comment its consideration of comments. The
study designs to establish the with confidential information that you second copy, which will have the
performance characteristics of in vitro do not wish to be made available to the claimed confidential information
diagnostic devices (IVDs) intended for public, submit the comment as a redacted/blacked out, will be available
the detection, or detection and written/paper submission and in the for public viewing and posted on
differentiation, of human manner detailed (see ‘‘Written/Paper https://www.regulations.gov. Submit
papillomaviruses (HPVs). This guidance Submissions’’ and ‘‘Instructions’’). both copies to the Dockets Management
VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1](https://thefederalregister.org/doc/82_FR_43564/page/1.svg)
![Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43387
Staff. If you do not wish your name and differentiation, of high risk HPV III. Electronic Access
contact information to be made publicly genotypes. These devices are used either
available, you can provide this in conjunction with cervical cytology to Persons interested in obtaining a copy
information on the cover sheet and not aid in screening for cervical cancer or as of the guidance may do so by
in the body of your comments and you first-line primary cervical cancer downloading an electronic copy from
must identify this information as screening devices. This guidance the internet. A search capability for all
‘‘confidential.’’ Any information marked provides recommendations for HPV Center for Devices and Radiological
as ‘‘confidential’’ will not be disclosed devices that detect a group of HPV Health guidance documents is available
except in accordance with 21 CFR 10.20 genotypes, particularly high risk HPVs, at http://www.fda.gov/MedicalDevices/
and other applicable disclosure law. For as well as devices that detect more than DeviceRegulationandGuidance/
more information about FDA’s posting one genotype of HPV and further GuidanceDocuments/default.htm.
of comments to public dockets, see 80 differentiate among them to indicate Guidance documents are also available
FR 56469, September 18, 2015, or access which genotypes of HPV are present. at https://www.regulations.gov. Persons
the information at: https://www.gpo.gov/ This guidance is expected to provide unable to download an electronic copy
fdsys/pkg/FR-2015-09-18/pdf/2015- detailed information on the types of of ‘‘Establishing the Performance
23389.pdf. studies FDA recommends to support a Characteristics of In Vitro Diagnostic
Docket: For access to the docket to premarket application for these devices. Devices for the Detection or Detection
read background documents or the and Differentiation of Human
This guidance is limited to studies
electronic and written/paper comments Papillomaviruses’’ may send an email
intended to establish the performance
received, go to https:// request to CDRH-Guidance@fda.hhs.gov
characteristics of in vitro diagnostic
www.regulations.gov and insert the
HPV devices that are used in to receive an electronic copy of the
docket number, found in brackets in the
conjunction with cervical cytology for document. Please use the document
heading of this document, into the
cancer screening or as first-line primary number 1740 to identify the guidance
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management cervical cancer screening devices. While you are requesting.
Staff, 5630 Fishers Lane, Rm. 1061, this guidance specifically addresses
devices that qualitatively detect HPV IV. Paperwork Reduction Act of 1995
Rockville, MD 20852.
An electronic copy of the guidance nucleic acid from cervical specimens, This guidance refers to previously
document is available for download but many of the recommendations will approved collections of information
from the internet. See the also be applicable to devices that detect found in FDA regulations. These
SUPPLEMENTARY INFORMATION section for
HPV proteins. This guidance provides collections of information are subject to
information on electronic access to the FDA’s recommendations for three types review by the Office of Management and
guidance. Submit written requests for a of cervical cancer screening modalities,
Budget (OMB) under the Paperwork
single hard copy of the guidance however, FDA does not make any
Reduction Act of 1995 (44 U.S.C. 3501–
document entitled ‘‘Establishing the assertions on which method of
screening is preferred. This guidance 3520). The collections of information in
Performance Characteristics of In Vitro 21 CFR part 814 have been approved
Diagnostic Devices for the Detection or does not address HPV testing from non-
cervical specimens such as pharyngeal, under OMB control number 0910–0231;
Detection and Differentiation of Human the collections of information in 21 CFR
Papillomaviruses’’ to the Office of the vaginal, penile, or anal specimens, or
testing for susceptibility to HPV part 812 have been approved under
Center Director, Guidance and Policy OMB control number 0910–0078; the
Development, Center for Devices and infection. It does not address
quantitative or semi-quantitative assays collections of information in 21 CFR
Radiological Health, Food and Drug
for HPV. parts 801 and 809 have been approved
Administration, 10903 New Hampshire
In the Federal Register of August 14, under OMB control number 0910–0485;
Ave., Bldg. 66, Rm. 5431, Silver Spring,
2015 (80 FR 48879), FDA announced the the collections of information in the
MD 20993–0002. Send one self-
addressed adhesive label to assist that availability of the draft of this guidance guidance document entitled ‘‘Informed
office in processing your request. and interested persons were invited to Consent For In Vitro Diagnostic Device
comment by November 12, 2015. FDA Studies Using Leftover Human
FOR FURTHER INFORMATION CONTACT:
has considered all of the public Specimens That Are Not Individually
Natalia Comella, Center for Devices and
Radiological Health, Food and Drug comments received in finalizing this Identifiable’’ have been approved under
Administration, 10903 New Hampshire guidance. OMB control number 0910–0582; and
Ave., Bldg. 66, Rm. 4536, Silver Spring, the collections of information in the
II. Significance of Guidance guidance document entitled ‘‘Requests
MD 20993–0002, 301–796–6226,
Natalia.Comella@fda.hhs.gov or Marina This guidance is being issued for Feedback on Medical Device
Kondratovich, Center for Devices and consistent with FDA’s good guidance Submissions: The Pre-Submission
Radiological Health, Food and Drug practices regulation (21 CFR 10.115). Program and Meetings with Food and
Administration, New Hampshire Ave., This guidance represents the current Drug Administration Staff’’ have been
Bldg. 66, Rm. 4672, Silver Spring, MD thinking of FDA on ‘‘Establishing the approved under OMB control number
20993–0002, 301–796–6036, Performance Characteristics of In Vitro 0910–0756.
Marina.Kondratovich@fda.hhs.gov. Diagnostic Devices for the Detection or Dated: September 6, 2017.
SUPPLEMENTARY INFORMATION: Detection and Differentiation of Human
mstockstill on DSK30JT082PROD with NOTICES
Anna K. Abram,
Papillomaviruses.’’ It does not establish
I. Background any rights for any person and is not Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
This guidance provides binding on FDA or the public. You can
[FR Doc. 2017–19612 Filed 9–14–17; 8:45 am]
recommendations to facilitate study use an alternative approach if it satisfies
designs to establish the performance the requirements of the applicable BILLING CODE 4164–01–P
characteristics of IVDs intended for the statutes and regulations. This guidance
detection, or detection and is not subject to Executive Order 12866.
VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 9990 E:\FR\FM\15SEN1.SGM 15SEN1](https://thefederalregister.org/doc/82_FR_43564/page/2.svg)
Document Created: 2017-09-15 00:18:44
Document Modified: 2017-09-15 00:18:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on September 15, 2017. | |
| 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, [email protected] 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, [email protected] | |
| FR Citation | 82 FR 43386 |
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