Notice2021-27894
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability
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Published
December 23, 2021
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, investigators, and other stakeholders entitled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations."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.
Full Text
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<title>Federal Register, Volume 86 Issue 244 (Thursday, December 23, 2021)</title>
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[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72981-72983]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Clinical Investigations; Draft Guidance for Industry, Investigators,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the availability of a draft guidance for industry, investigators, and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:
<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
[[Page 72982]]
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 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 <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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm</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 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
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