Notice2026-06184
Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments
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Published
March 31, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
Digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. As outlined in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have committed to supporting the use of DHTs in drug and biological product development. To inform potential FDA activities in this area, CDER and CBER are requesting information to better understand the opportunities and challenges sponsors and other interested parties face in making innovative use of DHTs in clinical investigations of drugs and biological products.
Full Text
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<title>Federal Register, Volume 91 Issue 61 (Tuesday, March 31, 2026)</title>
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[Federal Register Volume 91, Number 61 (Tuesday, March 31, 2026)]
[Notices]
[Pages 16006-16007]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06184]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2476]
Advancing the Use of Digital Health Technologies in Clinical
Investigations for Drugs and Biological Products; Request for
Information and Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; Request for information and comments.
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SUMMARY: Digital health technologies (DHTs) used for remote data
acquisition are playing a growing role in health care and offer
important opportunities in clinical research. As outlined in the sixth
reauthorization of the Prescription Drug User Fee Act (PDUFA VII)
included as part of the FDA User Fee Reauthorization Act of 2022, the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) have committed to supporting
the use of DHTs in drug and biological product development. To inform
potential FDA activities in this area, CDER and CBER are requesting
information to better understand the opportunities and challenges
sponsors and other interested parties face in making innovative use of
DHTs in clinical investigations of drugs and biological products.
DATES: Either electronic or written comments must be submitted by June
1, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 1, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2026-N-2476 for ``Advancing the Use of Digital Health Technologies
in Clinical Investigations for Drugs and Biological Products; Request
for Information and Comments.'' 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 <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
[[Page 16007]]
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.
FOR FURTHER INFORMATION CONTACT: Elizabeth Kunkoski, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 51, Rm 3332, Silver Spring, MD 20993, 301-796-
6439, <a href="/cdn-cgi/l/email-protection#f3b7bba780959c81b7818694b79685969f9c839e969d87b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="5f1b170b2c39302d1b2d2a381b3a293a33302f323a312b1f393b3e7137372c71383029">[email protected]</span></a>; or Mark Walderhaug, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 5270, Silver Spring, MD 20993-
0002, 240-402-8812 <a href="/cdn-cgi/l/email-protection#2d6e6f687f006965797f796d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="e6a5a4a3b4cba2aeb2b4b2a6808287c88e8e95c8818990">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
DHTs are systems that use computing platforms, connectivity,
software, and/or sensors for health care and related uses. DHTs include
technologies such as wearable, implantable, ingestible, and contactless
sensors. To advance the use of DHTs in drug and biological product
development and review, as part of PDUFA VII, FDA committed to
establishing a framework to guide the use of DHT-derived data in
regulatory decision-making for drugs and biological products.
CDER and CBER's Framework for the Use of DHTs in Drug and
Biological Product Development (March 2023) describes plans for
demonstration projects, public meetings, guidance development and
establishment of the DHT steering committee. Additionally, FDA's
December 2023 guidance entitled Digital Health Technologies for Remote
Data Acquisition in Clinical Investigations (2023 DHT Guidance)
outlines recommendations intended to facilitate the use of DHTs in
clinical investigations, as appropriate, for the evaluation of medical
products. These recommendations include selection of suitable DHTs,
verification and validation of DHTs, and use of DHTs to collect data
for clinical investigation endpoints.
Since the publication of the 2023 DHT Guidance, there have been
considerable advances in technology that may be used in clinical
investigations. The range of sensors and the clinical features they can
measure has expanded. Many of these sensors are present in smartwatches
and mobile phones and may be customized using mobile applications
(apps) for clinical investigations. Apps and other DHTs are being
designed to perform interactive clinical tests of patient function.
Examples include dynamometers to measure strength, apps to measure
coordination and fine motor skills, and accelerometers to measure
balance during specified tasks. Besides mechanical tasks, screen-based
technologies are being explored to test neuropsychiatric functions such
as reaction time, cognition, vision, hearing and to evaluate conditions
such as autism or post-traumatic stress disorder. CDER and CBER are
looking for ways to encourage the use of digitally derived endpoints
based on these novel technologies in clinical investigations.
In addition, DHTs are being designed specifically for pediatric use
and may play a role in evaluating new drugs and biological products in
children. Gamification is a promising strategy to engage children in
interactive clinical tests. Machine learning is also playing an
increased role in the development of algorithms for DHTs to measure
clinical features. Further opportunities for the innovative use of DHTs
in clinical investigations remain.
Given the expanding technological opportunities for the use of DHTs
in clinical drug and biological product development, we are seeking
public feedback on the opportunities and challenges that sponsors, and
other interested parties are experiencing in the use of DHTs in
clinical investigations of drugs and biological products. The
information and comments received in response to this notice will
inform the development of guidance documents, and other Agency
activities to support the appropriate use of DHTs in clinical
investigations of drugs and biological products.
II. Request for Information and Comments
Considering the progress around the use of DHTs in drug and
biological product development and the potential application of these
technologies as described above, CDER and CBER are requesting
information and comments on the questions below.
1. What regulatory challenges do DHT manufacturers, sponsors or
other interested parties face regarding the use of DHTs in clinical
investigations of drugs and biological products?
2. What opportunities are there for CDER and CBER to support and
facilitate the adoption of DHTs in clinical investigations of drugs and
biological products?
3. What areas of guidance would support the use of DHTs in clinical
investigations?
4. What specific DHT related topics, such as digitally derived
endpoints in certain disease areas, would benefit from discussion in a
public workshop?
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06184 Filed 3-30-26; 8:45 am]
BILLING CODE 4164-01-P
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