[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56059-56061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19763]
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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Software; Draft Guidance for Industry and Food and Drug Administration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the availability of the draft guidance entitled ``Computer Software
Assurance for Production and Quality System Software.'' FDA is issuing
this draft guidance to provide recommendations on computer software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
[[Page 56060]]
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
draft guidance is not final nor is it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by November 14, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-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 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
``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 or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, 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: Francisco Vicenty, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1534, Silver Spring, MD 20993-0002, 301-
796-5577; 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
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
the Quality System regulation, 21 CFR part 820, is required for
manufacturers of finished medical devices to the extent they engage in
operations to which part 820 applies. Recommending best practices
should promote product quality and patient safety, and correlate to
higher-quality outcomes. This draft 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. FDA has engaged with stakeholders to keep abreast of the
latest technologies and to better understand stakeholders' challenges
and opportunities for further advancement.
[[Page 56061]]
As part of these ongoing efforts, 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 lifecycle. 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 the validation
requirements of Sec. 820.70(i). For these reasons, FDA is providing
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. FDA invites comments on the computer
software assurance framework outlined in this guidance, including any
comments or questions regarding the application of 21 CFR part 11 to
requirements arising under Sec. 820.70(i) with respect to computers or
automated data processing systems used as part of production or the
quality system.
When final, this guidance will supplement FDA's guidance, ``General
Principles of Software Validation'' (``Software Validation guidance'')
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation), except this guidance
will supersede Section 6 (``Validation of Automated Process Equipment
and Quality System Software'') of the Software Validation guidance.
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 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 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. Persons unable to download an electronic copy of
``Computer Software Assurance for Production and Quality System
Software'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 17045 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 have been approved by
OMB as listed in the following table:
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OMB control
21 CFR part Topic No.
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11............................................ Electronic records; Electronic signatures....... 0910-0303
814, subparts A through E..................... Premarket approval.............................. 0910-0231
814, subpart H................................ Humanitarian Device Exemption................... 0910-0332
820........................................... Current Good Manufacturing Practice (CGMP); 0910-0073
Quality System (QS) Regulation.
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Dated: September 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19763 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P