Notice2022-20993
Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 28, 2022
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 "Clinical Decision Support Software." This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act).
Full Text
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<title>Federal Register, Volume 87 Issue 187 (Wednesday, September 28, 2022)</title>
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[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58810-58812]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20993]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6569]
Clinical Decision Support 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 ``Clinical Decision
Support Software.'' This final guidance provides clarity on FDA's
oversight of clinical decision support (CDS) software intended for
health care professionals with the purpose of describing FDA's
regulatory approach to CDS software functions. This guidance clarifies
the types of CDS functions that do not meet the definition of a device
as amended by the 21st Century Cures Act (Cures Act).
DATES: The announcement of the guidance is published in the Federal
Register on September 28, 2022.
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-2017-D-6569] for ``Clinical Decision Support Software; Guidance
for Industry and Food and Drug Administration Staff.'' 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 guidance document entitled
``Clinical Decision Support Software; Guidance for Industry and Food
and Drug Administration Staff'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire
[[Page 58811]]
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: Brendan O'Leary, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 301-
796-6898; 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 or Kristina
Lauritsen, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6162, Silver
Spring, MD 20993-0002, 301-796-8936.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has long regulated software that meets the definition of a
device in section 201(h) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 321(h)), including software that is intended to
provide decision support to health care professionals, patients, or
caregivers for the diagnosis, treatment, prevention, cure, or
mitigation of diseases or other conditions (often referred to as CDS
software). Section 3060(a) of the Cures Act, enacted on December 13,
2016 (Pub. L. 114-255), amended section 520 of the FD&C Act (21 U.S.C.
360j) to exclude certain medical software functions, including certain
decision support software, from the definition of device under section
201(h) of the FD&C Act.
This guidance describes CDS software functions that do not meet the
definition of a device in the context of and based on the criteria from
section 520(o) of the FD&C Act. This guidance also further clarifies
that FDA's existing digital health policies continue to apply to
software functions that meet the definition of a device, including
those that are intended for use by patients or caregivers. For example,
some decision support software functions may be identified in other
guidance documents as software functions for which, based on our
current understanding of the risks of these software functions, FDA
does not intend at this time to enforce compliance with applicable
device requirements of the FD&C Act, including, but not limited to,
premarket clearance and approval requirements.
A notice of availability of the draft guidance appeared in the
Federal Register of September 27, 2019 (84 FR 51167). FDA considered
comments received and revised the guidance as appropriate in response
to the comments. In this final guidance, FDA provides clarification on
the terminology of ``Clinical Decision Support'' and focuses solely on
the criteria for Non-Device CDS. In response to comments received, the
final guidance no longer contains complementary information from the
International Medical Device Regulators Forum risk categories, and the
guidance provides additional explanation for how a software function,
regardless of its complexity, can be intended for the purpose of
enabling a healthcare professional to independently review the basis
for the software function's recommendations, such that the
recommendations are not primarily relied upon by the healthcare
professional.
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 Clinical Decision Support 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>, <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>, or <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>.
Persons unable to download an electronic copy of ``Clinical Decision
Support Software; Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to <a href="/cdn-cgi/l/email-protection#97d4d3c5dfbad0e2fef3f6f9f4f2d7f1f3f6b9ffffe4b9f0f8e1"><span class="__cf_email__" data-cfemail="1a595e4852375d6f737e7b74797f5a7c7e7b34727269347d756c">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number 1400062 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, guidance, and forms
have been approved by OMB as listed in the following:
------------------------------------------------------------------------
21 CFR part; guidance; or FDA
form Topic OMB control 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 0910-0485
Labeling Regulations.
314........................... Applications for FDA 0910-0001
Approval to Market a
New Drug.
601; Form FDA 356h............ Biologics License; 0910-0338
Application to Market
a New Drug or
Abbreviated New Drug
or Biologic for Human
Use--Form FDA 356h.
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[[Page 58812]]
Dated: September 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20993 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P
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