Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 56059-56061 [2022-19763]
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
locate information, whether information
was located, and the type(s) of
information returned to the requesting
entity, are archived once a year based on
the fiscal year. The records are retained
for two completed fiscal years and then
destroyed. These records indicate the
type of information located for the
authorized user, not the information
itself.
(3) Match results generated as a result
of FCR-to-FCR comparisons which
locate individuals who are participants
in child support cases or orders in more
than one state are transmitted to the
relevant states. Copies of FCR-to-FCR
match results are retained for 60 days
and then deleted.
(4) Any record relating or potentially
relating to a fraud or abuse investigation
or a pending or ongoing legal action,
including a class action, is retained
until conclusion of the investigation or
legal action.
(5) Copies of the FCR records
transmitted to the Secretary of the
Treasury for the purpose of
administering sections of the Internal
Revenue Code which grant tax benefits
based on support or residence of
children (routine use 8) are retained for
one year and then deleted.
(6) Records collected or disseminated
for technical assistance to child support
agencies or other authorized agencies or
entities are retained for 60 days to five
years, and audit data is retained for a
period of up to two years.
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ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
The system leverages cloud service
providers that maintain an authority to
operate in accordance with applicable
laws, rules, and policies, including
Federal Risk and Authorization
Management Program (FedRAMP)
requirements. Specific administrative,
technical, and physical controls are in
place to ensure that the records
collected and maintained in the FCR are
secure from unauthorized access.
Access to the records is restricted to
authorized personnel who are advised
of the confidentiality of the records and
the civil and criminal penalties for
misuse and who sign a nondisclosure
oath to that effect. Personnel are
provided privacy and security training
before being granted access to the
records and annually thereafter. Logical
access controls are in place to limit
access to the records to authorized
personnel and to prevent browsing. The
records are processed and stored in a
secure environment. All records are
stored in an area that is physically safe
from access by unauthorized persons at
all times.
VerDate Sep<11>2014
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Jkt 256001
Safeguards conform to the HHS
Information Security and Privacy
Program, which may be found at https://
www.hhs.gov/ocio/securityprivacy/
index.html.
RECORD ACCESS PROCEDURES:
To request access to a record about
you, submit a written request to the
System Manager, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request should include your name,
telephone number and/or email address,
current address, and signature, and
sufficient particulars (such as, date of
birth or SSN) to enable the System
Manager to distinguish between records
on subject individuals with the same
name. To verify your identity, your
signature must be notarized or your
request must include your signed,
written certification that you are the
individual who you claim to be and that
you understand that the knowing and
willful request for or acquisition of a
record pertaining to an individual under
false pretenses is a criminal offense
subject to a fine of up to $5,000.
CONTESTING RECORD PROCEDURES:
To request correction of a record
about you in this system of records,
submit a written amendment request to
the System Manager, in accordance with
the Department’s Privacy Act
implementation regulations in 45 CFR.
The request must contain the same
information required for an access
request and include verification of your
identity in the same manner required for
an access request. In addition, the
request must reasonably identify the
record and specify the information
contested; the corrective action sought;
and the reasons for requesting the
correction; and should include
supporting justification or
documentation to show how the record
is inaccurate, incomplete, untimely, or
irrelevant.
records to the list of exempt systems of
records in HHS regulations
implementing the Privacy Act (45 CFR
5b, at 5b.11), and that exemption will be
effective upon publication of a Final
Rule. The Final Rule will, pursuant to
5 U.S.C. 552a(k)(2), exempt case files
marked with the Family Violence
Indicator (FVI), which constitute
investigatory material compiled for law
enforcement purposes, from the
accounting, access, and amendment
requirements in subsections (c)(3) and
(d)(1) through (4) of the Privacy Act (5
U.S.C. 552a(c)(3) and (d)(1) through (4)),
subject to the limitation set forth in
subsection (k)(2).
With respect to case files marked
‘‘FVI,’’ the exemption is intended to be
consistent with the disclosure
prohibition in section 453(b)(2) of the
Social Security Act (42 U.S.C. 653(b)(2))
which prohibits disclosure of case
records containing reasonable evidence
of domestic violence or child abuse,
disclosure of which could be harmful to
the custodial parent or the child of such
parent, to anyone other than a court or
an agent of the court. See also 45 CFR
303.21(e) (describing safeguarding
requirements for records marked with
the FVI).
HISTORY:
80 FR 17912 (Apr. 2, 2015), updated
83 FR 6591 (Feb. 14, 2018).
[FR Doc. 2022–19851 Filed 9–12–22; 8:45 am]
BILLING CODE 4184–42–P
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
NOTIFICATION PROCEDURES:
AGENCY:
To find out if this system of records
contains a record about you, submit a
written notification request to the
System Manager, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must identify this system of
records, contain the same information
required for an access request, and
include verification of your identity in
the same manner required for an access
request.
HHS.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
A notice of proposed rulemaking has
been published to add this system of
PO 00000
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56059
ACTION:
Food and Drug Administration,
Notice of availability.
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
SUMMARY:
E:\FR\FM\13SEN1.SGM
13SEN1
56060
Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
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’’).
jspears on DSK121TN23PROD with NOTICES
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–
VerDate Sep<11>2014
17:30 Sep 12, 2022
Jkt 256001
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-201509-18/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
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\13SEN1.SGM
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
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
§ 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 § 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/regulatoryinformation/search-fda-guidancedocuments/general-principles-softwarevalidation), 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
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:
OMB
control No.
Topic
11 ..............................................
814, subparts A through E .......
814, subpart H ..........................
820 ............................................
Electronic records; Electronic signatures .....................................................................................
Premarket approval ......................................................................................................................
Humanitarian Device Exemption ..................................................................................................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation .....................
[FR Doc. 2022–19763 Filed 9–12–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1999]
BILLING CODE 4164–01–P
Merck Sharp & Dohme Corp.;
Withdrawal of Approval of New Drug
Applications for VIOXX (Rofecoxib)
Tablets and Suspension
jspears on DSK121TN23PROD with NOTICES
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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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-bloodbiologics/guidance-complianceregulatory-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 CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 17045 and complete title to
identify the guidance you are
requesting.
21 CFR part
Dated: September 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
SUMMARY:
VerDate Sep<11>2014
17:30 Sep 12, 2022
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0910–0303
0910–0231
0910–0332
0910–0073
applications (NDAs) for VIOXX
(rofecoxib) Tablets, 12.5 milligrams
(mg), 25 mg, and 50 mg, and VIOXX
(rofecoxib) Suspension, 12.5 mg/5
milliliter (mL) and 25 mg/5 mL, held by
Merck Sharp & Dohme Corp., a
subsidiary of Merck & Co., Inc., P.O. Box
100, 1 Merck Dr., Whitehouse Station,
NJ 08889 (Merck). Merck has voluntarily
requested that FDA withdraw approval
of these applications and has waived its
opportunity for a hearing.
DATES: Approval is withdrawn as of
September 13, 2022.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
OMB control
21 CFR part Topic No.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
