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###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 14
          - [Docket No. FDA‐2024-N-0017]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Final rule.

# 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,                         *James.swink@fda.hhs.gov.*

# 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 § 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 § 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 § 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 

1. The authority citation for part 14 continues to read as follows: 

      ( print 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.                        

2. In § 14.100, add paragraph (d)(6) to read as follows: 

§ 14.100 

* * * * *

(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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