[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Notices]
[Pages 51165-51167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6294]


Changes to Existing Medical Software Policies Resulting From 
Section 3060 of the 21st Century Cures Act; 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 ``Changes to Existing 
Medical Software Policies Resulting From Section 3060 of the 21st 
Century Cures Act.'' This guidance provides clarity on FDA's current 
thinking regarding changes made by the 21st Century Cures Act (Cures 
Act) to the definition of a medical device and the resulting effect on 
guidances related to medical device software.

[[Page 51166]]


DATES: The announcement of the guidance is published in the Federal 
Register on September 27, 2019.

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-6294 for ``Changes to Existing Medical Software Policies 
Resulting from Section 3060 of the 21st Century Cures Act; 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 guidance document entitled 
``Changes to Existing Medical Software Policies Resulting from Section 
3060 of the 21st Century Cures Act'' 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. 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has long regulated software that meets the definition of a 
device. Section 3060(a) of the Cures Act, enacted on December 13, 2016 
(Pub. L. 114-255), amended the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) to exclude certain software functions from the definition of 
device under section 201(h) of the FD&C Act (21 U.S.C. 321(h)). The 
software functions that are removed from the definition of device are 
described in section 520(o)(1) of the FD&C Act (21 U.S.C. 360j(o)(1)), 
and the intended uses of such software functions can be summarized as 
follows: (1) For administrative support of a healthcare facility, (2) 
for maintaining or encouraging a healthy lifestyle, (3) to serve as 
electronic patient records, (4) for transferring, storing, converting 
formats, or displaying data, or (5) providing certain types of clinical 
decision support to a healthcare provider unless interpreting or 
analyzing a clinical test or other device data.
    This guidance provides FDA's current thinking regarding the amended 
device definition and the resulting effect the amended definition has 
on published FDA guidance, including the policies expressed in guidance 
about mobile medical applications; medical device data systems used for 
the electronic transfer, storage, display, or conversion of medical 
device data; medical image storage devices, used to store or retrieve 
medical images electronically; and general wellness products. This 
guidance focuses on the first four categories of software functions 
that are excluded from the device definition. FDA will address the 
fifth category in a separate guidance. Elsewhere in this

[[Page 51167]]

issue of the Federal Register, FDA is announcing the availability of 
the draft guidance entitled ``Clinical Decision Support Software'' to 
provide clarification of its interpretation of section 520(o)(1)(E) of 
the FD&C Act, which describes certain software functions intended to 
provide decision support for the diagnosis, treatment, prevention, 
cure, or mitigation of disease or other conditions. 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.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of December 8, 2017 (82 FR 57991). FDA 
revised the guidance as appropriate in response to the comments. FDA 
has provided additional clarity that hardware intended to transfer, 
store, convert formats, and display medical device data and results 
remain devices, while software functions intended to transfer, store, 
convert formats, or display data are no longer devices if they meet the 
definition in 520(o)(1)(D) of the FD&C Act. The examples included in 
the draft of this guidance that described alarms, alerts, or flags have 
been removed from this guidance, because they are not excluded from the 
definition of device under section 520(o)(1)(D) of the FD&C Act in that 
these functions involve analysis or interpretation of laboratory test 
or other device data and results. These functions are addressed in 
section 520(o)(1)(E) of the FD&C Act, the regulation of which will be 
described in the separate ``Clinical Decision Support Software'' 
guidance document.

II. Significance of Guidance

    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 ``Changes to Existing Medical Software 
Policies Resulting from Section 3060 of the 21st Century Cures Act.'' 
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 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 or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of ``Changes 
to Existing Medical Software Policies Resulting from Section 3060 of 
the 21st Century Cures Act'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 17030 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This 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 have been approved by OMB as listed in 
the following table:

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          21 CFR part                   Topic           OMB Control No.
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807, subparts A through D.....  Establishment                  0910-0625
                                 Registration And
                                 Device Listing.
807, subpart E................  Premarket                      0910-0120
                                 Notification.
800, 801, and 809.............  Medical Device                 0910-0485
                                 Labeling Regulations.
803...........................  Medical Devices;               0910-0437
                                 Medical Device
                                 Reporting;
                                 Manufacturer
                                 Reporting, Importer
                                 Reporting, User
                                 Facility Reporting,
                                 Distributor
                                 Reporting.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
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    Dated: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21001 Filed 9-26-19; 8:45 am]
BILLING CODE 4164-01-P


