[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58810-58812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 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 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 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, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. 
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 [email protected] 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


