[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Clinical Decision Support Software; Draft Guidance for Industry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the availability of the draft guidance entitled ``Clinical Decision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 This draft guidance is not final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DATES: Submit either electronic or written comments on the draft
guidance by December 26, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
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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 [email protected] 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:
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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