On July 23, 2024, Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) at FDA announced his intent to retire from FDA. During his tenure at FDA, Dr. Shuren was instrumental in helping lead innovation and regulatory modernization efforts within CDRH.
We have him to thank for clear regulation and guidance around the use of software as a medical device (SaMD) and more recently, charting regulation around the use of artificial intelligence in medical devices. He recognized the value of the patient voice to support diagnostic efficacy and elucidate safety signals when making regulatory decisions about novel and innovative devices. He is perhaps best known for his role in quickly mobilizing CDRH to authorize diagnostic testing and supportive medical devices to handle the COVID-19 pandemic. Dr. Shuren was particularly outspoken about the value of good working relationships and collaboration between FDA, industry, and the public. To this aim, he worked hard to increase the visibility of the regulatory process and establish greater common standards between US and ex-US health authorities.
Dr. Michelle Tarver is currently serving as acting Director of CDRH. She is board-certified in ophthalmology and holds a doctorate in epidemiology from Johns Hopkins University School of Medicine and Bloomberg School of Public Health.