Greenleaf Health, Inc. announces that Mark Kramer, former Director of the FDA’s Office of Combination Products (OCP), has joined the firm as Executive Vice President, Medical Devices and Combination Products.
Mark’s prior experience provides a unique perspective for Greenleaf clients seeking strategic guidance on the development and regulatory review of combination products as well as medical devices, drugs, and biological products. In addition to serving as Director of OCP from 2002 to 2007, Mark was also responsible for establishing the office. In this role, Mark oversaw the development of significant regulations, policies, and practices currently in effect for combination products, including the primary mode of action rule, the cGMP rule, the adverse event reporting rule, numerous guidance documents clarifying the regulation of combination products, and the intercenter consultation process. Mark also has a firsthand understanding, through his management of the FDA’s Product Jurisdiction Program, of how the Agency assigns combination products to Centers for review and determines the regulatory identity of drugs, devices, and biological products for which jurisdiction is unclear or in dispute.
Mark’s work is informed by his training as a biomedical engineer and a 35-year career in medical product regulation that has united technical, front-line regulatory skills with strategic advising and leadership. During his 17 years at the FDA, Mark gained extensive hands-on experience in device evaluation as a lead reviewer and supervisor for a broad range of products: cardiovascular, anesthesiology/respiratory, urology, gastroenterology, surgical, and dental.
Prior to joining Greenleaf, Mark headed an independent consulting practice for over 13 years (2009-2022), advising approximately 200 clients from across the globe, including sponsors of medical devices, combination products, drugs, and biological products, as well as breakthrough and orphan products. In addition to helping clients develop and refine their regulatory strategies, Mark supported sponsors’ regulatory submissions and FDA interactions at all stages of the regulatory process: authoring, strengthening, and submitting initial submissions; developing and critically reviewing responses to FDA-identified deficiencies; preparing for Agency and advisory panel meetings; and advising on cGMPs and adverse event reporting. Mark also spent three years in industry as Chief Regulatory Strategist for GE Healthcare’s medical device business, with executive responsibility for regulatory strategies, processes, and decisions throughout the U.S., Canada, and Latin America. Learn more about Mark Kramer.
About Greenleaf Health
Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Mark joins a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; Kate Cook, senior FDA leader in both CDRH and CBER; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; and Cynthia Schnedar, former Director of CDER’s Office of Compliance.
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.
For more information on Greenleaf Health, visit greenleafhealth.com.