[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


