8. Leadership changes at FDA
The U.S. Senate recently confirmed Dr. Stephen Hahn — previously CMO at Houston’s M.D. Anderson Cancer Center — as the new commissioner of the FDA. He’s the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April.
The FDA continues to look at ways to reform the medical device regulation process amid heightened media scrutiny, including including the International Consortium of Investigative Journalists’ “Implant Files” articles and the Netflix documentary “Bleeding Edge.” The agency, for example, has released draft guidances for the first four types of devices it will evaluate under its expedited Safety and Performance-Based Pathway to 510(k) clearance.