The FDA’s Center for Devices and Radiological Health (CDRH) is reorganizing this year to better integrate the center’s premarket and postmarket program functions and optimize decision making across the total life cycle of medical devices. The new organization will be aligned by the type of product being regulated. This will allow reviewers, compliance officers and other experts to work in teams and provide device oversight throughout a product’s development, commercialization, and market life. The biggest change will be to combine to Offices of Compliance, Device Evaluation, Surveillance and Biometrics, and the In Vitro Diagnostics and Radiological Health into one super office (the Office of Product Evaluation and Quality) focused on a Total Product Life Cycle approach to medical device oversight. The reorganization will also establish the Office of Strategic Partnerships and Technological Innovation, which combines the Science & Strategic Partnerships, Digital Health, Health Informatics and Innovation teams. This office appears to have been formed as early as March 18, 2019, and I note there are several vacancies in the Divisions of Digital Health and Technology and Data Services as of March 19th.
The full reorganization won’t be complete until the end of September. Here’s the CDRH management directory, which will be updated as the reorganization progresses. Read more about the change at the CDRH reorganization web site.
Postscript on September 28, 2021 – the management directory site is current, and its a great place to find connections.
Text Copyright © 2019 Katrina Rogers