BIO
Gina
Brackett
Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA
Gina Brackett is the Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH). She has been with the FDA for over 30 years. Prior to the reorganization of FDA on October 1, 2024, she was the Compliance Branch Director in ORA’s Office of Medical Devices and Radiological Health Office Division 1 for 7 years. Prior to her management positions, she served as a Compliance Officer in the Cincinnati District Officer for 15 years. She was a Medical Device Specialist for seven years and during this time was certified as a Level II Performance Auditor and conducted numerous complex medical device inspections.
