Washington E-Newsletter

Neurosurgery Supports Using Registry Data for FDA Regulatory Purposes

  • Drugs and Devices

On Feb. 20, the AANS and the CNS joined the Physician Clinical Registry Coalition in a letter to Food and Drug Administration Commissioner Robert M. Califf, MD, expressing support for using registry data as the agency develops guidance on using “real-world” data for medical device review. The letter was in response to draft guidance issued in December 2023.