Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 57991-57993 [2017-26442]
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Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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–N–6313 for ‘‘Prescription Drug
User Fee Act VI Commitment to Assess
Current Practices of the Food and Drug
Administration and Sponsors in
Communicating During Investigational
New Drug Development.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
VerDate Sep<11>2014
20:38 Dec 07, 2017
Jkt 244001
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/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Yoni Tyberg, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1151, Silver Spring,
MD 20993, 301–348–1718, Fax: 301–
847–8443, Yonatan.Tyberg@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The IND phase of drug development
is the time during which human trials
of investigational drugs are conducted.
During the IND phase, sponsors and
FDA engage in many types of
communications. To ensure the
effectiveness of human drug review
programs, it is critical that these
communications be conducted in a
timely and efficient manner.
The timely review of the safety and
effectiveness of new drugs and biologics
is central to FDA’s mission to protect
and promote the public health. Prior to
enactment of PDUFA in 1992, FDA’s
drug review process was relatively slow
and not very predictable compared to
that of other countries. Due to concerns
expressed by both industry and patients
at the time, Congress enacted PDUFA,
which provided the added funds
through user fees that enabled FDA to
hire additional reviewers and support
staff and upgrade its information
technology systems. In return for
additional resources, FDA agreed to
certain review performance goals, such
as completing reviews of new drug
applications and biologics license
applications and taking regulatory
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57991
actions on them in predictable
timeframes. These changes
revolutionized the drug approval
process in the United States and
enabled FDA to speed the application
review process for new drugs and
biologics without compromising the
Agency’s high standards for
demonstration of safety, efficacy, and
quality of new drugs and biologics prior
to approval.
PDUFA provides FDA with a source
of stable, consistent funding that has
made it possible for it to focus on
promoting innovative therapies and
help bring to market critical products
for patients. When PDUFA was
originally authorized in 1992, it had a
5-year term. The program has been
subsequently reauthorized every 5 years
with the most recent reauthorization
occurring in 2017 for fiscal years (FYs)
2018–2022. To prepare for the 2017
reauthorization of PDUFA, FDA
conducted negotiations with the
regulated industry and held regular
consultations with public stakeholders
including patient advocates, consumer
advocates, and health care professionals
between September 2015 and February
2016. Following these discussions,
related public meetings, and Agency
requests for public comment, FDA
published proposed recommendations
for PDUFA VI for FYs 2018–2022. FDA
committed under PDUFA VI to contract
with an independent third party to
assess current practices of FDA and
sponsors in communicating during IND
development and to identify best
practices and areas of improvement.
The statement of work can be
accessed at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM577087.pdf.
Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26437 Filed 12–7–17; 8:45 am]
BILLING CODE 4164–01–P
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; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\08DEN1.SGM
Notice of availability.
08DEN1
57992
Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Changes to Existing
Medical Software Policies Resulting
from Section 3060 of the 21st Century
Cures Act.’’ This draft 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. 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 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:
SUMMARY:
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’’).
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
20:38 Dec 07, 2017
Jkt 244001
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; 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/201523389.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)).
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Frm 00046
Fmt 4703
Sfmt 4703
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 ‘‘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 20993–0002, 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 (the FD&C Act) to exclude
certain medical software functions from
the definition of device under section
201(h) of the FD&C Act (21 U.S.C.
321(h)). Under sections 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, certain medical software
functions 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.
This draft guidance explains the effect
of the medical software provisions in
the Cures Act on preexisting FDA
policy, including policy on mobile
medical applications; medical device
E:\FR\FM\08DEN1.SGM
08DEN1
Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
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; medical
image communications devices, used to
transfer medical image data
electronically between medical devices;
software that automates laboratory
workflow; and low-risk general wellness
products. FDA intends to provide
clarification of its interpretation of
section 520(o)(1)(E) of the FD&C Act,
which is for software functions intended
to provide decision support for the
diagnosis, treatment, prevention, cure,
or mitigation of disease or other
conditions (often referred to as clinical
decision support software) in a separate
guidance document. 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 also intends to
provide recommendations on the
regulation of such products with
multifunctionality in a separate
guidance document.
sradovich on DSK3GMQ082PROD with NOTICES
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 ‘‘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 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/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm or https://
www.regulations.gov. 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
VerDate Sep<11>2014
20:38 Dec 07, 2017
Jkt 244001
copy of the document. Please use the
document number 17030 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft 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 820 have
been approved under OMB control
number 0910–0073; 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 803 have been approved under
OMB control number 0910–0437; 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. 2017–26442 Filed 12–7–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0508]
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised guidance for
industry entitled ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments.’’ This guidance is
intended to assist persons making
tobacco product establishment
registration and product listing
submissions to FDA.
DATES: The announcement of the
guidance is published in the Federal
Register on December 8, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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57993
• 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–
2009–D–0508 for ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments.’’ 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
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57991-57993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26442]
-----------------------------------------------------------------------
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; Draft Guidance for Industry
and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
[[Page 57992]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Changes to Existing
Medical Software Policies Resulting from Section 3060 of the 21st
Century Cures Act.'' This draft 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. 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 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 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; 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, 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
``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 20993-0002, 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
(the FD&C Act) to exclude certain medical software functions from the
definition of device under section 201(h) of the FD&C Act (21 U.S.C.
321(h)). Under sections 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, certain medical software
functions 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.
This draft guidance explains the effect of the medical software
provisions in the Cures Act on preexisting FDA policy, including policy
on mobile medical applications; medical device
[[Page 57993]]
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; medical image
communications devices, used to transfer medical image data
electronically between medical devices; software that automates
laboratory workflow; and low-risk general wellness products. FDA
intends to provide clarification of its interpretation of section
520(o)(1)(E) of the FD&C Act, which is for software functions intended
to provide decision support for the diagnosis, treatment, prevention,
cure, or mitigation of disease or other conditions (often referred to
as clinical decision support software) in a separate guidance document.
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 also intends to
provide recommendations on the regulation of such products with
multifunctionality in a separate guidance document.
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 ``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 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/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. 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 draft 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 820 have been approved under
OMB control number 0910-0073; 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 803 have been
approved under OMB control number 0910-0437; 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. 2017-26442 Filed 12-7-17; 8:45 am]
BILLING CODE 4164-01-P
