[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 [www.gpo.gov]
[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, [email protected].

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]
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