Notice2023-28262
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; Availability
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Published
December 22, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This guidance finalizes the draft guidance of the same title issued on December 23, 2021.
Full Text
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<title>Federal Register, Volume 88 Issue 245 (Friday, December 22, 2023)</title>
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[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88629-88631]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28262]
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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.
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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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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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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, <a href="/cdn-cgi/l/email-protection#cf8aa3a6b5aeadaabba7e184baa1a4a0bca4a68fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="50153c392a31323524387e1b253e3b3f233b39103634317e3838237e373f26">[email protected]</span></a>; 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, <a href="/cdn-cgi/l/email-protection#6228030f07114c2f1b071011220406034c0a0a114c050d14"><span class="__cf_email__" data-cfemail="81cbe0ece4f2afccf8e4f3f2c1e7e5e0afe9e9f2afe6eef7">[email protected]</span></a>; 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, <a href="/cdn-cgi/l/email-protection#420f2336362a27356c062b232f2d2c26022426236c2a2a316c252d34"><span class="__cf_email__" data-cfemail="dc91bda8a8b4b9abf298b5bdb1b3b2b89cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>; 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,
<a href="/cdn-cgi/l/email-protection#a4f4c5d1c88aefc8d1c1d0dee4c2c0c58accccd78ac3cbd2"><span class="__cf_email__" data-cfemail="e0b081958cceab8c9585949aa0868481ce888893ce878f96">[email protected]</span></a>.
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
<a href="https://www.fda.gov/media/151712/download?attachment">https://www.fda.gov/media/151712/download?attachment</a>.
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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
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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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="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/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</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28262 Filed 12-21-23; 8:45 am]
BILLING CODE 4164-01-P
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