March 21, 2019

FDA Prepares for New Acting Chief, Begins CDRH Reorganization

The U.S. Food and Drug Administration (FDA) has a new acting commissioner and plans to reorganize the Center for Devices and Radiological Health (CDRH).

Norman E. “Ned” Sharpless, MD, was named acting FDA commissioner last week to replace the departing commissioner, Scott Gottlieb, MD, who unexpectedly announced his resignation earlier this month. Gottlieb will continue in the position until the end of March.

Sharpless comes to the FDA after serving 16 months as director of the National Cancer Institute (NCI).

During that time, NCI saw its budget grow significantly, with the number of grants early-stage investigators increasing 25 percent. Prior to NCI, he served at the University of North Carolina-Lingberger Comprehensive Cancer Center.

Sharpless will join the FDA during an era of heightened activity on a variety of issues, including changes in agency approaches to the regulation of vaping, drugs and digital health.

In other news, the FDA recently announced the reorganization of the FDA Center for Devices and Radiological Health (FDA CDRH), the arm of the agency charged with oversight over medical devices. The effort is scheduled for completion in about September 2019.

The FDA CDRH reorganization is intended to take a more unified, team-based approach across the product lifecycle, integrating review, surveillance, quality and enforcement. It involves the consolidation of the CDRH Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health. They will be combined into one “super office,” to be called the Office of Product Evaluation and Quality.

Additionally, the reorganization would combine the Science and Strategic Partnerships, Digital Health, and Health Informatics and Innovation teams into the Office of Strategic Partnerships and Technological Innovation.