[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57987-57988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26439]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Clinical and Patient Decision Support Software; Draft Guidance 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the availability of the draft guidance entitled ``Clinical and Patient 
Decision Support Software.'' This draft guidance provides clarity on 
the scope of FDA's oversight of clinical decision support software 
intended for healthcare professionals, and patient decision support 
software intended for patients and caregivers who are not healthcare 
professionals. This draft guidance is not final nor is it in effect at 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DATES: Submit either electronic or written comments on the draft 
guidance by February 6, 2018 to ensure that the Agency considers your 
comment of this draft guidance before it begins work on the final 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-2017-D-6569 for ``Clinical and Patient Decision Support Software; 
Draft Guidance for Industry and Food and Drug Administration Staff; 
Availability.'' 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 office, 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 and Patient Decision Support Software'' to the Office of the 
Center Director, 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 20993-0002, 301-240-402-7911; or Kristina Lauritsen, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, Rm. 6158, 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 
(21 U.S.C. 321(h)) (FD&C Act), including software that is intended to 
provide decision support for the diagnosis, treatment, prevention, 
cure, or mitigation of

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diseases or other conditions (often referred to as clinical decision 
support software). Similar software functions may be intended for use 
by patients. This draft guidance provides clarity on the scope of FDA's 
oversight of: (1) Clinical decision support software intended for 
healthcare professionals, and (2) patient decision support software 
intended for patients and caregivers who are not healthcare 
professionals.
    FDA recognizes that the term ``clinical decision support'' or 
``CDS'' is used broadly and in different ways, depending on the 
context. This draft guidance defines ``CDS'' in the context of and 
using language from section 3060(a) of the 21st Century Cures Act 
(Cures Act), which amended section 520 of the FD&C Act (21 U.S.C. 360j) 
and excludes certain software functions from the device definition. The 
purpose of this guidance is to identify the types of decision support 
software functionalities that: (1) Do not meet the definition of a 
device, in light of the Cures Act; (2) may meet the definition of a 
device but for which FDA does not intend to enforce compliance with 
applicable requirements of the FD&C Act, including, but not limited to, 
premarket clearance and premarket approval requirements; and (3) FDA 
intends to focus its regulatory oversight on.

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 and 
Patient 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/MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/default.htm. Guidance 
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov. Persons unable to download an electronic 
copy of ``Clinical and Patient Decision Support Software'' 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 guidance refers to previously approved collections of 
information found in FDA regulations. 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 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subparts A 
through E, have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 814, subpart H have been 
approved under OMB control number 0910-0332; the collections of 
information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338; the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR parts 801 and 809 have been 
approved under OMB control number 0910-0485.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26439 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P


