[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60838-60840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0775]


Content of Premarket Submissions for Device Software Functions; 
Draft Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 60839]]


ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Content of Premarket 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 the 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). When final, this document will 
replace FDA's ``Guidance for the Content of Premarket Submissions for 
Software Contained in Medical Devices'' issued on May 11, 2005, and it 
will update FDA's thinking related to the documentation FDA recommends 
sponsors include for the review of device software functions in 
premarket submissions. This draft guidance is not final nor is it in 
effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 2, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-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 draft guidance document entitled 
``Content of Premarket Submissions for Device Software Functions'' 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; 
or the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002, 301-796-5528; 
or Stephen Ripley, 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.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of this draft 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 recent changes to 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st 
Century Cures Act (Pub. L. 114-255), which amended section 520 of the 
FD&C Act (21 U.S.C. 360) 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.

[[Page 60840]]

    This draft guidance identifies the software information generally 
necessary for evaluating the safety and effectiveness of a device in a 
premarket submission. The recommendations in this draft guidance also 
may help facilitate FDA's premarket review. This draft guidance 
describes information that typically would be 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.
    When final, this document will replace FDA's ``Guidance for the 
Content of Premarket Submissions for Software Contained in Medical 
Devices'' issued on May 11, 2005, and it will update FDA's thinking 
related to the documentation recommended for the review of device 
software functions in premarket submissions.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current 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 draft 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/biologics-guidances. 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 337 and complete title to identify the 
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no 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:

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21 CFR part; guidance; or FDA                               OMB control
             form                        Topic                  No.
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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.
``De Novo Classification       De Novo classification          0910-0844
 Process (Evaluation of         process.
 Automatic Class III
 Designation)''.
800, 801, and 809............  Medical Device Labeling         0910-0485
                                Regulations.
820..........................  Current Good                    0910-0073
                                Manufacturing Practice
                                (CGMP); Quality System
                                (QS) Regulation.
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    Dated: October 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24061 Filed 11-3-21; 8:45 am]
BILLING CODE 4164-01-P


