Center for Devices and Radiological Health’s 2021 annual report – Describes the division’s work in 2021, including that devoted to pandemic response and granting emergency use authorization to thousands of medical devices focused on COVID-19. Available for free download.
Guiding Principles for Good Machine Learning Practice for Medical Device Development – The U.S. Food and Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency in 2021 identified 10 guiding principles to help promote safe, effective and high-quality medical devices that use artificial intelligence and machine learning.
All of Us Research Program – National Institutes of Health program to gather data on 1 million or more people living in the United States to advance precision medicine. The program incorporated wearable devices into its data-gathering operations.