[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 [email protected]
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:
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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]
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