Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability, 72981-72983 [2021-27894]
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Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
72981
TABLE 2—GUIDANCES AND COLLECTIONS
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
814, subpart H ............................................................................
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)’’.
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
803 ..............................................................................................
Premarket notification ................................................................
Premarket approval ....................................................................
Humanitarian Device Exemption ...............................................
De Novo classification process ..................................................
0910–0120
0910–0231
0910–0332
0910–0844
Q-submissions ...........................................................................
0910–0756
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor
reporting.
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
Electronic Submission of Medical Device Registration and
Listing.
Corrections and Removals ........................................................
Unique Device Identification ......................................................
Medical Device Labeling ............................................................
Emergency Use Authorization ...................................................
0910–0437
820 ..............................................................................................
807, subparts A through D .........................................................
806 ..............................................................................................
830 and 801.20 ...........................................................................
800, 801, and 809 .......................................................................
‘‘Emergency Use Authorization of Medical Products and Related Authorities’’.
IV. Other Issues for Consideration
As discussed in the draft guidance,
FDA understands that it will take time
for device manufacturers, healthcare
facilities, healthcare providers, patients,
consumers, and FDA to adjust from
policies adopted and operations
implemented during the declared PHE
to normal operations. FDA encourages
all stakeholders to comment on the
following topics:
1. Whether the 180-day period
proposed for advance notice of
termination of each EUA declaration
pertaining to devices would sufficiently
allow for an appropriate transition
period that avoids exacerbating product
shortages and supply chain disruptions.
2. Whether FDA’s issuance of this
draft guidance with a proposed
transition policy and requesting public
comment may help the Agency to
satisfy, or otherwise determine how to
best satisfy, while also effectively
managing Agency resources, the
requirement in section 564(b)(2)(B) of
the FD&C Act to consult with a
manufacturer that was issued an EUA
for an unapproved product on the
appropriate disposition of the product.
Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
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OMB Control
No.
21 CFR part or guidance
[FR Doc. 2021–27891 Filed 12–22–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
20:50 Dec 22, 2021
Jkt 256001
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.
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.
SUMMARY:
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0910–0073
0910–0625
0910–0359
0910–0720
0910–0485
0910–0595
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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
E:\FR\FM\23DEN1.SGM
23DEN1
jspears on DSK121TN23PROD with NOTICES1
72982
Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
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-201509-18/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)).
VerDate Sep<11>2014
20:50 Dec 22, 2021
Jkt 256001
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 selfaddressed 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
PO 00000
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Fmt 4703
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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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Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
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.
jspears on DSK121TN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, 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]
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VerDate Sep<11>2014
20:50 Dec 22, 2021
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4206]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Small Business Qualification
and Certification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on Form FDA 3602
and Form FDA 3602A, on which
domestic and foreign applicants certify
that they qualify as a small business and
pay certain medical device user fees at
reduced rates.
DATES: Submit either electronic or
written comments on the collection of
information by February 22, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 22,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 22, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
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
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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–
2018–N–4206 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device User Fee Small Business
Qualification and Certification.’’
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
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
E:\FR\FM\23DEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[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 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
[[Page 72983]]
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
