On January 31, 2022, FDA published the Center for Devices and Radiological Health (CDRH) Annual Report. The report discusses the establishment of the Digital Health Center of Excellence to enable patients, healthcare practitioners, researchers, and medical device firms to advance healthcare.
The Digital Health Center reports that there is an increasing number of medical devices with software incorporating AI and ML. CDRH has reviewed and authorized over 300 devices with AI/ML across many different fields, including more than 50 authorized in 2021.
Most of the devices that rely on AI/ML fall into the category of SaMD or software intended to perform one or more medical purposes without being part of a hardware medical device. CDRH has released a 5-part AI/ML-Based SaMD Action Plan that describes a multi-pronged approach to advance FDA’s oversight of AI/ML based medical software.
In December 2021, FDA issued the draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations guidance for Industry Investigators, and other stakeholders. The goal is to provide recommendations to sponsors, investigators, and other stakeholders on using digital health technologies to acquire data remotely from participants in clinical investigations evaluating medical products.
Also, in 2021 CDRH authorized, cleared, or approved 13 devices with breakthrough designation. One of the devices approved is the first non-surgical heart valve to treat pediatric and adult patients with a native or surgically repaired right ventricular outflow tract. This is the part of the heart that carries blood out of the right ventricle to the lungs. The device called the Harmony Transcatheter Pulmonary Valve System was developed by Medtronic. https://www.medtronic.com.