Notice2025-18468
Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
September 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Computer Software Assurance for Production and Quality System Software." FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. FDA believes that these recommendations will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA.
Full Text
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<title>Federal Register, Volume 90 Issue 183 (Wednesday, September 24, 2025)</title>
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[Federal Register Volume 90, Number 183 (Wednesday, September 24, 2025)]
[Notices]
[Pages 45945-45947]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18468]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0795]
Computer Software Assurance for Production and Quality System
Software; Guidance for Industry and Food and Drug Administration Staff;
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 guidance entitled ``Computer Software
Assurance for Production and Quality System Software.'' FDA is issuing
this guidance to provide recommendations on computer software assurance
for computers and automated data processing systems used as part of
medical device production or the quality system. FDA believes that
these recommendations will help foster the adoption and use of
innovative technologies that promote patient access to high-quality
medical devices and help manufacturers to keep pace with the dynamic,
rapidly changing technology landscape, while promoting compliance with
laws and regulations implemented by FDA.
DATES: The announcement of the guidance is published in the Federal
Register on September 24, 2025.
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:
<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-2022-D-0795 for ``Computer Software Assurance for Production and
Quality System Software.'' 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
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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 guidance document entitled
``Computer Software Assurance for Production and Quality System
Software'' 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: Daniel Walter, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1526, Silver Spring, MD 20993-0002, 301-796-5587 or
Phillip Kurs, Center for Biologics Evaluation and Research, Food and
Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA envisions a future state where the medical device ecosystem is
inherently focused on device features and manufacturing practices that
promote product quality and patient safety. FDA has sought to identify
and promote successful manufacturing practices and help device
manufacturers raise their manufacturing quality level. In doing so, one
goal is to help manufacturers produce high-quality medical devices that
align with the laws and regulations implemented by FDA. Compliance with
quality system obligations including those in 21 CFR part 820 is
required for manufacturers of finished medical devices to the extent
they engage in operations to which those obligations apply. This
guidance addresses practices relating to computers and automated data
processing systems used as part of production or the quality system.
FDA recognizes the potential for advances in manufacturing
technologies, including the adoption of automation, robotics,
simulation, and other digital capabilities, to provide significant
benefits for enhancing the quality, availability, and safety of medical
devices. Medical device manufacturers have expressed a desire for
greater clarity regarding the Agency's expectations for software
validation for computers and automated data processing systems used as
part of production or the quality system. Given the rapidly changing
nature of software, manufacturers have also expressed a desire for a
more iterative, agile approach for validation of computer software used
as part of production or the quality system.
Traditionally, software validation has often been accomplished via
software testing and other verification activities conducted at each
stage of the software development life cycle. However, software testing
alone is often insufficient to establish confidence that the software
is fit for its intended use. FDA believes that applying a risk-based
approach to computer software used as part of production or the quality
system would better focus manufacturers' assurance activities to help
ensure product quality while helping to fulfill validation
requirements. This guidance provides recommendations on computer
software assurance for computers and automated data processing systems
used as part of medical device production or the quality system. FDA
believes that these recommendations will help foster the adoption and
use of innovative technologies that promote patient access to high-
quality medical devices and help manufacturers to keep pace with the
dynamic, rapidly changing technology landscape, while promoting
compliance with laws and regulations implemented by FDA.
This guidance supplements FDA's guidance entitled ``General
Principles of Software Validation,'' \1\ except this guidance
supersedes Section 6 (``Validation of Automated Process Equipment and
Quality System Software'') of the ``General Principles of Software
Validation'' guidance.
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\1\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation</a>.
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A notice of availability of the draft guidance appeared in the
Federal Register of September 13, 2022 (87 FR 56059). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including adding a definitions section to provide
clarity on commonly used terms in the guidance, updating examples of
manual and automated testing, and adding examples throughout the
guidance that apply the concepts in the guidance to different types of
software.
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 Computer Software Assurance for Production
and Quality System Software. 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 <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">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Computer Software Assurance for Production and Quality System
Software'' may send an email request to <a href="/cdn-cgi/l/email-protection#87c4c3d5cfaac0f2eee3e6e9e4e2c7e1e3e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="7e3d3a2c3653390b171a1f101d1b3e181a1f5016160d50191108">[email protected]</span></a> to
receive an electronic copy of the document. Please use the document
number GUI00017045 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. The
previously approved collections of information are subject to review by
OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
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3521). The collections of information in the following table have been
approved by OMB:
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21 CFR part; guidance; or FDA OMB control
form Topic No.
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11.............................. Electronic records; 0910-0303
Electronic signatures.
814, subparts A through E....... Premarket approval...... 0910-0231
814, subpart H.................. Humanitarian Device 0910-0332
Exemption.
820............................. Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18468 Filed 9-23-25; 8:45 am]
BILLING CODE 4164-01-P
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