[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38870-38872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12723]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0775]
Content of Premarket Submissions for Device Software Functions;
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 a final guidance entitled ``Content of Premarket
Submissions for Device Software Functions.'' This guidance document is
intended to provide information regarding the recommended documentation
sponsors should include in premarket submissions for FDA's evaluation
of safety and effectiveness of device software functions, which are
functions that meet the definition of a device under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). This document replaces FDA's
``Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices'' issued on May 11, 2005, and updates
FDA's thinking related to the documentation FDA recommends sponsors
include for the review of device software functions in premarket
submissions.
DATES: The announcement of the guidance is published in the Federal
Register on June 14, 2023.
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
[[Page 38871]]
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-2021-D-0775 for ``Content of Premarket Submissions for Device
Software Functions.'' 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, 240-
402-7500.
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, 240-402-7500.
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
``Content of Premarket Submissions for Device Software Functions'' to
the Office of Policy, 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: Brendan O'Leary, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 301-
796-6898; Diane Maloney, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993, 240-402-7911; Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-0002, 301-796-
3400; or John Weiner, Office of Combination Products, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5130 HFG-3,
Silver Spring, MD 20993-0002, 301-796-8941.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of this guidance is to describe FDA's thinking on the
recommended documentation sponsors should include in premarket
submissions for FDA's evaluation of the safety and effectiveness of
device software functions. This thinking recognizes changes to the FD&C
Act made by the 21st Century Cures Act (Cures Act), which amended
section 520 of the FD&C Act (21 U.S.C. 360j) and excludes certain
software functions from the device definition. It also considers the
rapidly evolving nature of digital health and recent FDA recognized
consensus standards related to software.
The recommendations in this guidance are intended to facilitate
FDA's premarket review. This guidance describes information that would
be typically generated and documented during software development,
verification, and design validation. The least burdensome approach was
applied to identify the minimum amount of information that, based on
our experience, would generally be needed to support a premarket
submission for a device that uses software. During premarket review,
FDA may request additional information that is needed to evaluate the
submission.
This document replaces FDA's ``Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices''
issued on May 11, 2005, and updates FDA's thinking related to the
documentation FDA recommends sponsors include for the review of device
software functions in premarket submissions.
A notice of availability of the draft guidance appeared in the
Federal Register of November 4, 2021 (86 FR 60838). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including edits to clarify FDA's risk-based approach
to determining a device's Documentation Level (including an expanded
Appendix of examples that illustrate application of the Documentation
Level risk-based approach) as well as edits to clarify the recommended
documentation that should be included within a premarket submission.
The guidance also clarifies that the recommendations generally apply to
the device constituent part of a combination product when the device
constituent part includes a device software function, including
combination products assigned to FDA's Center for Drug Evaluation and
Research (CDER) or Center for Biologics Evaluation and Research (CBER)
regulated under drug or biological product market submission types. FDA
also edited the document to further clarify the recommended utilization
of FDA-recognized versions of consensus standards, where appropriate,
within a premarket submission.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current
[[Page 38872]]
thinking of FDA on ``Content of Premarket Submissions for Device
Software Functions.'' 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.
II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Content of Premarket Submissions for Device Software Functions'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI00000337 and complete title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:
------------------------------------------------------------------------
21 CFR part; guidance; or FDA OMB control
form Topic No.
------------------------------------------------------------------------
807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Device 0910-0332
Exemption.
812............................ Investigational Device 0910-0078
Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
601; Form FDA 356h............. Biologics License; 0910-0338
Application to Market
a New or Abbreviated
New Drug or Biologic
for Human Use--Form
FDA 356h.
``Requests for Feedback and Q-submissions.......... 0910-0756
Meetings for Medical Device
Submissions: The Q-Submission
Program''.
800, 801, and 809.............. Medical Device Labeling 0910-0485
Regulations.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
------------------------------------------------------------------------
Dated: June 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12723 Filed 6-13-23; 8:45 am]
BILLING CODE 4164-01-P