Document ID: FDA-2016-D-2565-0019
Agency: fda
Document Type: Notice
Title: The 510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
Posted Date: 2020-03-12T04:00Z

[Federal Register Volume 85, Number 49 (Thursday, March 12, 2020)]
[Notices]
[Pages 14489-14491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05080]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2565]

The 510(k) Third Party Review Program; Guidance for Industry, 
Food and Drug Administration Staff, and Third Party Review 
Organizations; 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 a final

[[Page 14490]]

guidance entitled ``510(k) Third Party Review Program.'' This guidance 
provides a comprehensive look into FDA's current thinking regarding the 
510(k) Third Party (3P510k) Review Program authorized under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization 
Act of 2017 (FDARA), FDA was directed to issue guidance on the factors 
that will be used in determining whether a class I or class II device 
type, or subset of such device types, is eligible for review by an 
accredited person. The 3P510k Review Program is intended to allow 
review of devices by 3P510k Review Organizations in order to provide 
manufacturers of these devices an alternative review process that 
allows FDA to best utilize our resources on higher risk devices.

DATES: The announcement of the guidance is published in the Federal 
Register on March 12, 2020.

ADDRESSES: You may submit either electronic or written 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-2016-D-2565 for ``510(k) Third Party Review Program.'' 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 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.govinfo.gov/content/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``510(k) Third Party Review Program'' to the Office of Policy, 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: Gregory Pishko, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3441, Silver Spring, MD 20993-0002, 240-402-6635.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's implementation of section 523 of the FD&C Act (21 U.S.C. 
360m) establishes a process for recognition of qualified third parties 
to conduct the initial review of premarket notification (510(k)) 
submissions for certain low-to-moderate risk devices eligible under the 
3P510k Review Program. Under FDARA (Pub. L. 115-52), the criteria used 
to establish device eligibility in the 3P510k Review Program changed 
and FDA was directed to issue guidance on the factors that will be used 
in determining whether a class I or class II device type, or subset of 
such device types, is eligible for review by an accredited person. The 
objectives of this guidance are to describe the factors FDA will use in 
determining device type eligibility for review by 3P510k Review 
Organizations; to outline FDA's process for the recognition, 
rerecognition, suspension and withdrawal of recognition for 3P510k 
Review Organizations; and to ensure consistent quality of work among 
3P510k Review Organizations through Medical Device User Fee Amendments 
IV commitments authorized under FDARA in order to eliminate the need 
for routine, substantive re-review by FDA. This guidance also outlines 
FDA's current thinking on leveraging the International Medical Device 
Regulators Forum's requirements for Regulatory Reviewers under the Good 
Regulatory Review Practices and the Medical Device Single Audit 
Program.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of September 14, 2018 (83 FR 46742). 
FDA revised the

[[Page 14491]]

guidance as appropriate in response to the comments. This guidance 
supersedes ``Implementation of Third Party Programs Under the FDA 
Modernization Act of 1997; Final Guidance for Staff, Industry, and 
Third Parties'' issued on February 2, 2001, and ``Guidance for Third 
Parties and FDA Staff; Third Party Review of Premarket Notifications'' 
issued on September 28, 2004.

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 
current thinking of FDA on the 510(k) Third Party Review Program. 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.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``510(k) Third Party 
Review Program'' may send an email request to CDRH-Guidance@fda.hhs.gov 
to receive an electronic copy of the document. Please use the document 
number 17-028 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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. 3501-3521). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
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807...............................  Medical Devices:           0910-0375
                                     Third-Party Review
                                     under FDAMA.
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Center for Devices and            CDRH Appeals Process       0910-0738
 Radiological Health (CDRH)
 Appeals Processes''.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
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    Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05080 Filed 3-11-20; 8:45 am]
BILLING CODE 4164-01-P