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), FDA. She has been with the FDA for over 30 years. Prior to her current position, 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. Brackett is a member of numerous workgroups and has helped develop new procedures to assure a smooth transition since ORA’s program alignment in May of 2017.
