[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Software; Draft Guidance for Industry and Food and Drug Administration 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the availability of the draft guidance entitled ``Computer Software 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this draft guidance to provide recommendations on computer software 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draft guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by November 14, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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


