[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72981-72983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27894]


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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Clinical Investigations; Draft Guidance for Industry, Investigators, 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the availability of a draft guidance for industry, investigators, and 
other stakeholders entitled ``Digital Health Technologies for Remote 
Data Acquisition in Clinical Investigations.'' This guidance provides 
recommendations to sponsors, investigators, and other stakeholders on 
the use of digital health technologies (DHTs) to acquire data remotely 
from participants in clinical investigations evaluating medical 
products. DHTs may take the form of hardware and/or software and may be 
used to gather health-related information from study participants and 
transmit that information to study investigators and/or other 
authorized parties to evaluate the safety and effectiveness of medical 
products.

DATES: Submit either electronic or written comments on the draft 
guidance by March 23, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

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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 the draft 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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
the Office of Policy, 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. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft 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, 301-796-
6439; Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993, 240-402-7911; or 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for 
industry, investigators, and other stakeholders entitled ``Digital 
Health Technologies for Remote Data Acquisition in Clinical 
Investigations.'' Advances in sensor technology, general-purpose 
computing platforms, and methods for data transmission and storage have 
revolutionized the ability to remotely obtain and analyze clinically 
relevant information from individuals. DHTs used for remote data 
acquisition are playing a growing role in healthcare and offer 
important opportunities in clinical research. DHTs provide 
opportunities to record data directly from trial participants (e.g., 
ambulation, sleep, performance of everyday tasks) wherever the 
participants may be (e.g., home, school, work, outdoors); this may 
provide a broader picture of how participants function in their daily 
lives. DHTs may also facilitate the direct collection of information 
from participants who are unable to report their experiences (e.g., 
infants, cognitively impaired individuals).
    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 (1) selection of DHTs that are suitable for use in a clinical 
investigation; (2) the description of DHTs in regulatory submissions; 
(3) verification and validation of DHTs for use in a clinical 
investigation; (4) the definition and evaluation of clinical endpoints 
from data collected using DHTs; (5) risk management considerations when 
using DHTs; (6) the protection and retention of records; and (7) 
additional sponsor and investigator considerations for using DHTs in a 
clinical investigation.
    On October 29, 2015, FDA published a notice in the Federal Register 
(80 FR 66543) establishing a public docket (FDA-2015-N-3579) to solicit 
input from a broad group of stakeholders on the scope and direction of 
the use of technologies and innovative methods in the conduct of 
clinical trials. FDA considered relevant stakeholder comments received 
to the public docket when writing this draft 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 ``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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by the OMB under the PRA. 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

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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 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 draft 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27894 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P