The US FDA have formed a new Advisory Committee on Digital Health Technologies (DHTs) to help address different issues related to DHTs such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will also advise the FDA on these issues, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The committee should be fully operational in 2024.
The Breakthrough Devices Program is a voluntary program for medical and IVD devices that provide more effective treatment or diagnosis of irreversible or life-threatening diseases. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. The FDA is hosting a public webinar on Breakthrough Devices Program Updated Final Guidance to discuss the guidance and share how this program can help advance health equity. The webinar is hosted on 14 November from 1-2pm ET. More details on this webinar can be found here.