
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70679-70680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22566]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3941]


Advisory Committee; Digital Health Committee; Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of establishment.

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SUMMARY: Under the Federal Advisory Committee Act, the Food and Drug 
Administration (FDA or Agency) is announcing the establishment of the 
Digital Health Advisory Committee. The Commissioner of Food and Drugs 
(Commissioner) has determined that it is in the public interest to 
establish such a committee. Duration of this committee is 2 years from 
the date the Charter is filed, unless the Commissioner formally 
determines that renewal is in the public interest.

DATES: Either electronic or written comments on the notice must be 
submitted by December 11, 2023. FDA is establishing a docket for public 
comment on this document. The docket number is FDA-2023-N-3941. The 
docket will close on December 11, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 11, 2023. 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:
     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-2023-N-3941 for ``Advisory Committee; Digital Health Committee; 
Establishment.'' Received comments, those filed in a timely manner, 
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.'' FDA 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 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 the 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.

FOR FURTHER INFORMATION CONTACT: James Swink, Office of Management, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver 
Spring, MD 20993, 301-796-6313, [email protected].

SUPPLEMENTARY INFORMATION: The Digital Health Advisory Committee 
(Committee) provides advice to the Commissioner or designee, on complex 
scientific and technical issues related to digital health technologies 
(DHTs). This also may include advice on the regulation of DHTs, and/or 
their use, including use of DHTs in clinical trials or postmarket 
studies subject to FDA regulation. Topics relating to DHTs, such as 
artificial intelligence/machine learning (AI/ML), augmented reality, 
virtual reality, digital therapeutics, wearables, remote patient 
monitoring, and software, may be considered by the Committee. The 
Committee advises the Commissioner on issues related to DHTs, 
including, for example, real-world data, real-world evidence, patient-
generated health data, interoperability, personalized medicine/
genetics, decentralized clinical trials, use of DHTs in clinical trials 
for medical products, cybersecurity, DHT user experience, and Agency 
policies and regulations regarding these technologies. The Committee 
provides relevant expertise and perspective to improve Agency 
understanding of the benefits, risks, and clinical outcomes associated 
with use of DHTs. The Committee performs its duties by providing advice 
and recommendations on new approaches to develop and evaluate DHTs and 
to promote innovation of DHTs, as well as identifying risks, barriers, 
or unintended consequences that could result from proposed or 
established Agency policy or regulation for topics related to DHTs.
    The Committee shall consist of a core of nine voting members 
including the Chair. Members and the Chair are

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selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of digital health, such as AI/ML, augmented 
reality, virtual reality, digital therapeutics, wearables, remote 
patient monitoring, software development, user experience, real-world 
data, real-world evidence, patient-generated health data, 
interoperability, personalized medicine/genetics, decentralized 
clinical trials, cybersecurity, and implementation in clinical practice 
of and patient experience with digital health, as well as other 
relevant areas. Members will be invited to serve for overlapping terms 
of up to 4 years. Non-Federal members of this committee will serve 
either as special government employees or non-voting representatives. 
Federal members will serve as regular government employees. The core of 
voting members may include one technically qualified member, selected 
by the Commissioner or designee, who serves as an individual, but who 
is identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons.
    The Commissioner or designee shall also have the authority to 
select from a group of individuals nominated by industry to serve 
temporarily as non-voting members who are identified with and represent 
industry interests. The number of temporary members selected for a 
particular meeting will depend on the meeting topic.
    In announcing the establishment of this Advisory Committee under 
the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.), FDA is also 
soliciting public feedback on potential topics for this committee to 
discuss and upon which to advise the Agency. The following topics may 
include, but are not limited to:

 Transparency and bias management considerations, including 
promoting health equity in DHTs
 Augmented reality and virtual reality technical and clinical 
questions
 Transparency and labeling considerations for ``opaque box'' 
algorithms
 Digital therapeutics
 AI/ML
 Input on regulation of AI/ML-enabled devices
 Real-world data and real-world evidence
 Patient-generated health data
 Postmarket monitoring considerations for a total product 
lifecycle approach to DHTs
 Interoperability
 Personalized medicine/genetics
 Wearables, remote patient monitoring, and internet of things
 Postmarket monitoring of DHTs
 Technologies to enable decentralized clinical trials
 Cybersecurity best practices in software development for 
cloud-based software

    Elsewhere in this issue of the Federal Register, FDA is publishing 
separate documents regarding: (1) Digital Health Advisory Committee: 
Request for Nominations for Voting Members on a Public Advisory 
Committee: Digital Health Advisory Committee; (2) Request for 
Nomination of Individuals and Consumer Organizations for the Digital 
Health Advisory Committee; and (3) Request for Nomination of 
Individuals and Industry Organizations for the Digital Health Advisory 
Committee.
    FDA intends to publish in the Federal Register a final rule adding 
the Digital Health Advisory Committee to 21 CFR 14.100.

    Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22566 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P


