Rule2024-03618
Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
Primary source
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Published
February 22, 2024
Effective
February 22, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committees regulations to add the establishment of the Digital Health Advisory Committee (the Committee) to the list of standing advisory committees.
Full Text
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<title>Federal Register, Volume 89 Issue 36 (Thursday, February 22, 2024)</title>
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[Federal Register Volume 89, Number 36 (Thursday, February 22, 2024)]
[Rules and Regulations]
[Pages 13268-13269]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03618]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA[hyphen]2024-N-0017]
Advisory Committee; Digital Health Advisory Committee; Addition
to List of Standing Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
the standing advisory committees regulations to add the establishment
of the Digital Health Advisory Committee (the Committee) to the list of
standing advisory committees.
DATES: This rule is effective February 22, 2024.
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, <a href="/cdn-cgi/l/email-protection#80cae1ede5f3aef3f7e9eeebc0e6e4e1aee8e8f3aee7eff6"><span class="__cf_email__" data-cfemail="cd87aca0a8bee3bebaa4a3a68daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Committee was established on October 11,
2023, and notice of establishment was published in the Federal Register
on October 12, 2023 (88 FR 70679).
The Committee will provide 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, augmented reality,
virtual reality, digital therapeutics, wearables, remote patient
monitoring, and software, may be considered by the Committee. The
Committee will advise 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
will provide relevant expertise and perspective to improve Agency
understanding of the benefits, risks, and clinical outcomes associated
with use of DHTs. The Committee will perform 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 selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of digital health, such as artificial intelligence/machine
learning, 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.
The Committee name and function have been established with the
establishment of the Committee charter. The change became effective
October 11, 2023. Therefore, the Agency is amending Sec. 14.100 (21
CFR 14.100) to add the Committee name and function to its current list
as set forth in the regulatory text of this document.
Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e),
the Agency finds good cause to dispense with notice and public comment
procedures and to proceed to an immediate effective date on this rule.
Notice and public comment and a delayed effective date are unnecessary
and are not in the public interest as this final rule merely amends
Sec. 14.100 to include the name of the committee and its function that
will be added consistent with the committee charter.
Therefore, the Agency is amending Sec. 14.100 as set forth in the
regulatory text of this document.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
0
1. The authority citation for part 14 continues to read as follows:
[[Page 13269]]
Authority: 5 U.S.C. 1001 et seq.; 15 U.S.C. 1451-1461; 21 U.S.C.
41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264, 284m, 284m-1; Pub. L. 107-109, 115 Stat.
1419.
0
2. In Sec. 14.100, add paragraph (d)(6) to read as follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(d) * * *
(6) Digital Health Advisory Committee.
(i) Date established: October 11, 2023.
(ii) Function: Advises the Commissioner of Food and Drugs or
designee in discharging responsibilities as they relate to ensuring
that digital health technologies (DHTs) intended for use as a stand-
alone medical product, as part of a medical product, or as a companion,
complement, or adjunct to a medical product are safe and effective for
human use.
* * * * *
Dated: February 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03618 Filed 2-21-24; 8:45 am]
BILLING CODE 4164-01-P
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