[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 [email protected] 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]
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