Notice2021-24061
Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
November 4, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Content of Premarket Submissions for Device Software Functions."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 This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 86 Issue 211 (Thursday, November 4, 2021)</title>
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[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60838-60840]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Draft Guidance for Industry and Food and Drug Administration Staff;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the availability of the draft guidance entitled ``Content of Premarket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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>. Persons unable to download
an electronic copy of ``Content of Premarket Submissions for Device
Software Functions'' may send an email request to <a href="/cdn-cgi/l/email-protection#b4f7f0e6fc99f3c1ddd0d5dad7d1f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="773433253f5a30021e131619141237111316591f1f0459101801">[email protected]</span></a> 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
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