[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]


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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guidance finalizes the draft guidance of the same title issued on 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:
     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

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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/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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