Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; Availability, 88629-88631 [2023-28262]
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Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28244 Filed 12–21–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1128]
Digital Health Technologies for Remote
Data Acquisition in Clinical
Investigations; Guidance for Industry,
Investigators, and Other Stakeholders;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry, investigators, and
other stakeholders entitled ‘‘Digital
Health Technologies for Remote Data
Acquisition in Clinical Investigations.’’
This guidance provides
recommendations on the use of digital
health technologies (DHTs) to acquire
data remotely from participants in
clinical investigations that evaluate
medical products. DHTs for remote data
acquisition in clinical investigations can
include hardware and/or software to
perform one or more functions. Use of
DHTs as recommended in this guidance
may improve the efficiency of clinical
trials for sponsors, investigators, and
other stakeholders and may increase the
opportunities for individuals to
participate in research and make
participation more convenient. This
guidance finalizes the draft guidance of
the same title issued on December 23,
2021.
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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
Notice of availability.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on December 22, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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–
2021–D–1128 for ‘‘Digital Health
Technologies for Remote Data
Acquisition in Clinical Investigations.’’
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, 240–402–7500.
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• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002; or the Office of Policy, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
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Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Kunkoski, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3332,
Silver Spring, MD 20993–0002, 301–
796–6439, Elizabeth.Kunkoski@
fda.hhs.gov; James Myers, 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, James.Myers@
fda.hhs.gov; Matthew Diamond, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
5540, Silver Spring, MD 20993–0002,
301–796–5386, Matthew.Diamond@
fda.hhs.gov; or Paul Kluetz, Oncology
Center of Excellence, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2223, Silver Spring,
MD 20993, 301–796–9567, Paul.Kluetz@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Digital
Health Technologies for Remote Data
Acquisition in Clinical Investigations.’’
This guidance addresses requirements
set forth in section 3607(a) of the Food
and Drug Omnibus Reform Act of 2022
(FDORA) and meets a Prescription Drug
User Fee Act (PDUFA) Reauthorization
Performance Goal to finalize guidance
on DHTs (section IV.C.5.b of the PDUFA
VII commitment letter).1 This guidance
provides recommendations for ensuring
that a DHT is fit-for-purpose (i.e., that
the level of validation associated with
the DHT is sufficient to support its use,
including the interpretability of its data
in the clinical investigation), which
involves considerations of both the
DHT’s form (i.e., design) and function(s)
(i.e., distinct purpose within an
investigation). DHTs may rely on or
work with other technologies, such as
general-purpose computing platforms
(e.g., smartphones) and communication
networks, for remote data acquisition in
a clinical investigation. Compared to
intermittent trial visits, the use of DHTs
to remotely collect data from trial
participants may allow for continuous
or more-frequent data collection. This
may provide a broader picture of how
participants feel or function in their
1 PDUFA VII: Fiscal Years 2023–2027 | FDA
available at https://www.fda.gov/media/151712/
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daily lives. DHTs provide opportunities
to record data directly from trial
participants (e.g., biomarkers,
performance of activities of daily living,
sleep, vital signs) wherever the
participants may be (e.g., home, school,
work, outdoors). The data collection
may involve passive monitoring by the
DHT or the acquisition of data while
participants are actively interacting with
the DHT.
This guidance outlines
recommendations intended to facilitate
the use of DHTs in a clinical
investigation as appropriate for the
evaluation of medical products. The
guidance provides recommendations on,
among other things: (1) selection of
DHTs that are suitable for use in clinical
investigations; (2) the description of
DHTs in regulatory submissions; (3)
verification and validation of DHTs for
use in clinical investigations; (4) use of
DHTs to collect data for trial endpoints;
(5) identification and management of
risks associated with the use of DHTs
during clinical investigations; (6)
retention and protection of data
collected by DHTs; and (7) the roles of
sponsors and investigators related to the
use of DHTs in clinical investigations.
This guidance finalizes the draft
guidance of the same title issued on
December 23, 2021 (86 FR 72981). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include clarification
regarding the meaning of DHT
function(s) for the purposes of the
guidance; further explanation of
regulatory considerations for DHTs that
meet the definition of a device under
section 201(h) of the Federal Food,
Drug, and Cosmetic Act; clarification
regarding the use of participants’ own
DHTs or other technologies in clinical
investigations; inclusion of references to
Form FDA 1571 and Form FDA 356h for
tracking submissions that include DHT
data; revisions to the verification,
validation and usability evaluations
section; clarification on DHT record
protection and retention; clarification
on the sponsor and investigator’s roles;
and further recommendations on
handling DHT updates and other
changes during clinical investigations.
In addition, editorial changes were
made to improve clarity.
Section 3607(a) of FDORA requires
FDA to, within 1 year of enactment,
issue or revise draft guidance regarding
the appropriate use of DHTs in clinical
trials. This provision of FDORA further
requires that, not later than 18 months
after the end of the public comment
period on the draft guidance, FDA must
issue a revised draft guidance or final
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guidance. This guidance revises and
finalizes a draft guidance on use of
DHTs in clinical trials issued December
23, 2021. Most of the content required
to be included in guidance under
FDORA section 3607(a) was included in
the draft version of this guidance that
was open to public comment and such
comments were considered in finalizing
this guidance. The few additions to
address the remaining FDORA section
3607(a) content requirements are minor.
As noted above, you may submit
comments on a guidance at any time. As
with any guidance, FDA will consider
comments received and issue any
further revisions that we determine to
be appropriate, consistent with 21 CFR
10.115. To ensure that the Agency
considers your comments in
determining if any further revisions to
this guidance are appropriate, submit
your comments by February 20, 2024.
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 ‘‘Digital Health
Technologies for Remote Data
Acquisition in Clinical Investigations.’’
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.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 11 have been
approved under OMB control number
0910–0303; the collections of
information in 21 CFR part 312,
including submissions under subpart E,
and 21 CFR 312.41, 312.57, 312.58,
312.62, and 312.120 have been
approved under OMB control number
0910–0014; the collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information under 21 CFR part 807,
subpart E, have been approved under
OMB control number 0910–0120; the
collections of information under 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information under 21 CFR part 814,
subpart H, have been approved under
OMB control number 0910–0332; the
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collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information for the De
Novo Classification Process (Evaluation
of Automatic Class III Designation) have
been approved under OMB control
number 0910–0844; and the collections
of information in the guidance
document entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ have been approved under
OMB control number 0910–0756. The
collections of information in 21 CFR
part 314 (Applications for FDA
Approval to Market a New Drug) and 21
CFR part 601 (General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension) have been approved under
OMB control numbers 0910–0001 and
0910–0338, respectively. The
collections of information in 21 CFR
parts 50 and 56 (Protection of Human
Subjects: Informed Consent;
Institutional Review Boards) have been
approved under OMB control number
0910–0130.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances,https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28262 Filed 12–21–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1146]
Real-World Data: Assessing Registries
To Support Regulatory DecisionMaking for Drug and Biological
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘RealWorld Data: Assessing Registries to
Support Regulatory Decision-Making for
Drug and Biological Products.’’ This
guidance provides considerations for
sponsors proposing to design a registry
or to use an existing registry to support
regulatory decision-making about a
drug’s effectiveness or safety. FDA is
issuing this guidance as part of its RealWorld Evidence (RWE) Program and to
satisfy, in part, the mandate under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to issue guidance on the use
of RWE in regulatory decision-making.
This guidance finalizes the draft
guidance of the same title issued on
November 30, 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on December 22, 2023.
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:
• 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.
PO 00000
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• 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–
2021–D–1146 for ‘‘Real-World Data:
Assessing Registries to Support
Regulatory Decision-Making for Drug
and Biological Products.’’ 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, 240–402–7500.
• 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
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Agencies
[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88629-88631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28262]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1128]
Digital Health Technologies for Remote Data Acquisition in
Clinical Investigations; Guidance for Industry, Investigators, and
Other Stakeholders; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry, investigators, and
other stakeholders entitled ``Digital Health Technologies for Remote
Data Acquisition in Clinical Investigations.'' This guidance provides
recommendations on the use of digital health technologies (DHTs) to
acquire data remotely from participants in clinical investigations that
evaluate medical products. DHTs for remote data acquisition in clinical
investigations can include hardware and/or software to perform one or
more functions. Use of DHTs as recommended in this guidance may improve
the efficiency of clinical trials for sponsors, investigators, and
other stakeholders and may increase the opportunities for individuals
to participate in research and make participation more convenient. This
guidance finalizes the draft guidance of the same title issued on
December 23, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on December 22, 2023.
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-2021-D-1128 for ``Digital Health Technologies for Remote Data
Acquisition in Clinical Investigations.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
[[Page 88630]]
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Kunkoski, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3332, Silver Spring, MD 20993-0002, 301-
796-6439, [email protected]; James Myers, 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, [email protected]; Matthew Diamond, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5540, Silver Spring, MD 20993-0002,
301-796-5386, [email protected]; or Paul Kluetz, Oncology
Center of Excellence, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2223, Silver Spring, MD 20993, 301-796-9567,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Digital Health Technologies for Remote Data Acquisition in
Clinical Investigations.'' This guidance addresses requirements set
forth in section 3607(a) of the Food and Drug Omnibus Reform Act of
2022 (FDORA) and meets a Prescription Drug User Fee Act (PDUFA)
Reauthorization Performance Goal to finalize guidance on DHTs (section
IV.C.5.b of the PDUFA VII commitment letter).\1\ This guidance provides
recommendations for ensuring that a DHT is fit-for-purpose (i.e., that
the level of validation associated with the DHT is sufficient to
support its use, including the interpretability of its data in the
clinical investigation), which involves considerations of both the
DHT's form (i.e., design) and function(s) (i.e., distinct purpose
within an investigation). DHTs may rely on or work with other
technologies, such as general-purpose computing platforms (e.g.,
smartphones) and communication networks, for remote data acquisition in
a clinical investigation. Compared to intermittent trial visits, the
use of DHTs to remotely collect data from trial participants may allow
for continuous or more-frequent data collection. This may provide a
broader picture of how participants feel or function in their daily
lives. DHTs provide opportunities to record data directly from trial
participants (e.g., biomarkers, performance of activities of daily
living, sleep, vital signs) wherever the participants may be (e.g.,
home, school, work, outdoors). The data collection may involve passive
monitoring by the DHT or the acquisition of data while participants are
actively interacting with the DHT.
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\1\ PDUFA VII: Fiscal Years 2023-2027 [verbar] FDA available at
https://www.fda.gov/media/151712/download?attachment.
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This guidance outlines recommendations intended to facilitate the
use of DHTs in a clinical investigation as appropriate for the
evaluation of medical products. The guidance provides recommendations
on, among other things: (1) selection of DHTs that are suitable for use
in clinical investigations; (2) the description of DHTs in regulatory
submissions; (3) verification and validation of DHTs for use in
clinical investigations; (4) use of DHTs to collect data for trial
endpoints; (5) identification and management of risks associated with
the use of DHTs during clinical investigations; (6) retention and
protection of data collected by DHTs; and (7) the roles of sponsors and
investigators related to the use of DHTs in clinical investigations.
This guidance finalizes the draft guidance of the same title issued
on December 23, 2021 (86 FR 72981). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include clarification regarding the meaning
of DHT function(s) for the purposes of the guidance; further
explanation of regulatory considerations for DHTs that meet the
definition of a device under section 201(h) of the Federal Food, Drug,
and Cosmetic Act; clarification regarding the use of participants' own
DHTs or other technologies in clinical investigations; inclusion of
references to Form FDA 1571 and Form FDA 356h for tracking submissions
that include DHT data; revisions to the verification, validation and
usability evaluations section; clarification on DHT record protection
and retention; clarification on the sponsor and investigator's roles;
and further recommendations on handling DHT updates and other changes
during clinical investigations. In addition, editorial changes were
made to improve clarity.
Section 3607(a) of FDORA requires FDA to, within 1 year of
enactment, issue or revise draft guidance regarding the appropriate use
of DHTs in clinical trials. This provision of FDORA further requires
that, not later than 18 months after the end of the public comment
period on the draft guidance, FDA must issue a revised draft guidance
or final guidance. This guidance revises and finalizes a draft guidance
on use of DHTs in clinical trials issued December 23, 2021. Most of the
content required to be included in guidance under FDORA section 3607(a)
was included in the draft version of this guidance that was open to
public comment and such comments were considered in finalizing this
guidance. The few additions to address the remaining FDORA section
3607(a) content requirements are minor. As noted above, you may submit
comments on a guidance at any time. As with any guidance, FDA will
consider comments received and issue any further revisions that we
determine to be appropriate, consistent with 21 CFR 10.115. To ensure
that the Agency considers your comments in determining if any further
revisions to this guidance are appropriate, submit your comments by
February 20, 2024.
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 ``Digital Health Technologies for Remote
Data Acquisition in Clinical Investigations.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 11 have been approved under OMB control number 0910-
0303; the collections of information in 21 CFR part 312, including
submissions under subpart E, and 21 CFR 312.41, 312.57, 312.58, 312.62,
and 312.120 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485; the collections of information under 21
CFR part 807, subpart E, have been approved under OMB control number
0910-0120; the collections of information under 21 CFR part 814,
subparts A through E, have been approved under OMB control number 0910-
0231; the collections of information under 21 CFR part 814, subpart H,
have been approved under OMB control number 0910-0332; the
[[Page 88631]]
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information for the De
Novo Classification Process (Evaluation of Automatic Class III
Designation) have been approved under OMB control number 0910-0844; and
the collections of information in the guidance document entitled
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' have been approved under OMB control number
0910-0756. The collections of information in 21 CFR part 314
(Applications for FDA Approval to Market a New Drug) and 21 CFR part
601 (General Licensing Provisions: Biologics License Application,
Changes to an Approved Application, Labeling, Revocation and
Suspension) have been approved under OMB control numbers 0910-0001 and
0910-0338, respectively. The collections of information in 21 CFR parts
50 and 56 (Protection of Human Subjects: Informed Consent;
Institutional Review Boards) have been approved under OMB control
number 0910-0130.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28262 Filed 12-21-23; 8:45 am]
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