[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Notices]
[Pages 51167-51169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6569]


Clinical Decision Support Software; Draft Guidance for Industry 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the availability of the draft guidance entitled ``Clinical Decision 
Support Software.'' This guidance clarifies the types of clinical 
decision support (CDS) functions that do not meet the definition of a 
device as amended by the 21st Century Cures Act (Cures Act). This 
guidance describes a risk-based approach for regulatory oversight of 
CDS software functions that remain devices using the categories defined 
by the International Medical Device Regulators Forum (IMDRF) final 
document entitled ``Software as a Medical Device: Possible Framework 
for Risk Categorization and Corresponding Considerations.'' The 
guidance also provides clarity on the types of CDS software functions 
on which FDA intends to focus its regulatory oversight for health care 
providers, patients, and caregivers. This draft guidance is not final 
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 26, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 51168]]

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; Draft 
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.
     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.gpo.gov/fdsys/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.
    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 
``Clinical Decision Support Software; Draft 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 Ave., Bldg. 66, Rm. 
5431, Silver Spring, MD 20993-0002; or 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; or Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002. Send one self-addressed adhesive label to assist that 
office in processing your request.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002, 301-796-5528; 
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 draft guidance provides clarity on the types of CDS software 
functions that do not meet the device definition (Non Device CDS). This 
draft guidance also describes a risk-based approach for regulatory 
oversight of CDS software functions that meet the device definition 
(Device CDS) using categories established by the IMDRF final document 
entitled ``Software as a Medical Device: Possible Framework for Risk 
Categorization and Corresponding Considerations.'' The purpose of this 
draft guidance is to identify the types of CDS software functions that: 
(1) Do not meet the definition of a device as amended by the Cures Act; 
(2) may meet the definition of a device but for which, at this time and 
based on our current understanding of the risk of these devices, FDA 
does not intend to enforce compliance with the applicable device 
requirements of the FD&C Act, including, but not limited to, premarket 
clearance and premarket approval requirements; and (3) meet the 
definition of a device and on which FDA intends to focus its regulatory 
oversight. This guidance also provides examples of device software 
functions that are not CDS and on which FDA intends to focus its 
regulatory oversight. Elsewhere in this issue of the Federal Register, 
FDA is announcing the availability of the final guidance entitled 
``Changes to Existing Medical Software Policies Resulting From

[[Page 51169]]

Section 3060 of the 21st Century Cures Act'' to provide clarification 
of its interpretation of section 520(o)(1)(A)-(D) of the FD&C Act (21 
U.S.C. 360j(o)(1)(A)-(D)), as added by the Cures Act, for certain 
medical software functions that are not medical devices, including 
software functions that are intended: (1) For administrative support of 
a health care facility, (2) for maintaining or encouraging a healthy 
lifestyle, (3) to serve as electronic patient records, or (4) for 
transferring, storing, converting formats, or displaying data. Section 
520(o)(2) of the FD&C Act describes the regulation of a product with 
multiple functions, including at least one device function and at least 
one software function that is not a device. FDA intends to provide 
recommendations on the regulation of such products with 
multifunctionality in a separate guidance document.
    On December 8, 2017, FDA announced in the Federal Register a draft 
guidance entitled ``Clinical and Patient Decision Support Software'' 
(82 FR 57987). FDA is issuing a revised draft guidance, now entitled 
``Clinical Decision Support Software,'' after considering comments 
received on the draft guidance that issued December 8, 2017. This draft 
guidance provides FDA's risk-based policy for Device CDS software 
functions in response to comments received.

II. Significance of 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 ``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. This guidance is not subject to Executive 
Order 12866.

III. 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/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; Draft Guidance 
for Industry and Food and Drug Administration Staff'' may send an email 
request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of 
the document. Please use the document number 1400062 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
the following FDA regulations, guidance, and form have been approved by 
OMB as listed in the following table:

 
------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                       Topic           OMB Control No.
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807, subpart E................  Premarket                      0910-0120
                                 Notification.
814, subparts A through E.....  Premarket Approval...          0910-0231
814, subpart H................  Humanitarian Device            0910-0332
                                 Exemption.
812...........................  Investigational                0910-0078
                                 Device Exemption.
``De Novo Classification        De Novo                        0910-0844
 Process (Evaluation of          Classification
 Automatic Class III             Process.
 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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    Dated: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21000 Filed 9-26-19; 8:45 am]
BILLING CODE 4164-01-P


