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 In this section:

                Digital Health Center of Excellence

Digital Health Center of Excellence

                        Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
          Digital Health Frequently Asked Questions (FAQs)
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          FDA Digital Health Advisory CommitteeDigital Health Center of Excellence FDA Digital Health Advisory Committee
  
  	
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    PrintFDA's Digital Health Advisory Committee is now accepting applications through December 11, 2023. Image of people with talk bubbles of digital health icons.
What Is the Goal of the Digital Health Advisory Committee?

Digital Health is a rapidly evolving, cross-cutting space that spans a wide range of technologies, such as artificial intelligence and machine learning, virtual reality, or wearables; and issues such as decentralized clinical trials, patient generated health data, or cybersecurity.

To support safe and effective regulation of digital health technologies while encouraging innovation, the FDA is establishing a Digital Health Advisory Committee to consider this topic and related issues, and to solicit views from technical and scientific subject matter experts from diverse disciplines and backgrounds.

The Digital Health Advisory Committee will advise the Commissioner of Food and Drugs on issues related to Digital Health Technologies (DHTs), and FDA policies and regulations about these technologies, providing relevant expertise and perspective to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with use of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. This also may include advice on the use of DHTs in clinical trials or post-market studies subject to the FDA's regulation.

Committee Membership

The Committee shall consist of a core of 9 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. The number of temporary members selected for a particular meeting will depend on the meeting topic.

Meetings of the Committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws and policies of the U.S. Department of Health and Human Services.

For information about how to nominate yourself or another candidate to participate in the Committee, see Applying for Membership on FDA Advisory Committees.

Federal Register Notices

Industry representatives
	Consumer organizations
	Voting members**Contact Information**

James Swink
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66
Silver Spring, MD 20993-0002
telephone:301-796-6313
fax: 301-847-8510
e-mail: james.swink@fda.hhs.gov

                                                                                  Content current as of:
      01/08/2024
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  						              
			
			
			
			
			
			
			  
			  Digital HealthDigital Health Center of Excellence

          
                        Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
          Digital Health Frequently Asked Questions (FAQs)
          Digital Health Center of Excellence Services
          About the Digital Health Center of Excellence
          Network of Digital Health Experts
          What is Digital Health?
          Cybersecurity
          Digital Health Terms
          Guidances with Digital Health Content
          Digital Health Policy Navigator
          Digital Health Reports
          FDA Digital Health Advisory Committee
          Medical Device Interoperability
          Digital Health Research and Partnerships
          Augmented Reality and Virtual Reality in Medical Devices


                        Diagnostic Data Program
          Software as a Medical Device (SaMD)
          Device Software Functions Including Mobile Medical Applications
          Wireless Medical Devices
          Digital Health Software Precertification (Pre-Cert) Pilot Program
 
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