Kirtida Patel is an investigator and a device specialist at FDA- ORA Office of Medical Device and Radiological Health West, Div. 3.
During her FDA career of 18+ years, she conducted hundreds of complex device inspections and investigations, both domestic and international including the pre-market approval inspections and Electronic Products and Radiation Control inspections. She conducted inspections of IVD heart valves, catheters, stents, surgical devices, CT-Scanner and X-Ray, laser, bone and other implant manufacturers. She also conducted clinical research (BIMO) inspections of sponsors, clinical investigators, CROs and IRBs of both devices and drugs. Many of her inspections resulted in FDA regulatory actions of warning letters, untitled letters, injunctions and recalls, import detention and export hold of the firm’s devices. She is also cross trained in Compliance and Recalls.
Prior to FDA, for approximately 20 years, she worked in medical device and pharmaceutical firms where she held management positions in quality, regulatory and compliance.
She holds degrees in Chemistry/Biochemistry, Medical Technology and Respiratory Therapy