Practice Area Focus
- Combination Products
- Regulatory Strategy
- Premarket Submission Strategy
- CGMPs for Combination Products
- Requests for Designation
Mark Kramer joined NDA Partners in 2013. He is a former regulatory affairs executive with the medical device division of GE Healthcare. Prior to that, he worked for the US Food & Drug Administration (FDA) where he established and directed the Office of Combination Products. Mr. Kramer also directed the FDA’s Product Jurisdiction Program, which was established to ensure prompt assignment of drug-device, drug-biologic, and device-biologic combination products to agency Centers, and determine regulatory identity of drugs, devices and biological products for which jurisdiction is unclear or in dispute.
Before heading the Office of Combination Products, Mr. Kramer was Chief of FDA’s Anesthesiology and Defibrillator Devices Branch, Chief of the Urology and Lithotripsy Devices Branch, Acting Associate Director for Plastic Surgery and Dental Devices, and a lead reviewer for pacing and electrophysiology devices. Prior to joining FDA, Mr. Kramer worked in product development in the medical device industry.