Greenleaf Health helped a digital therapeutic company developing cognitive treatments as it navigated the de novo classification request regulatory pathway. Greenleaf experts worked closely with the client to address FDA concerns and requests regarding the digital therapeutic device, helping to clarify the FDA’s questions and recommendations and assisting with drafting written correspondence to the Agency. With Greenleaf’s …
Mark Kramer
Executive Vice President, Medical Devices and Combination Products
Background:
17-year FDA career that included leading interdisciplinary review teams in CDRH and directing the Office of Combination Products | M.S., Biomedical Engineering
Specialty:
FDA regulation of combination products and medical devices
Experience:
Founding Director of the FDA's Office of Combination Products | 14 years as a strategic regulatory consultant for medical device, combination product, drug, and biological product clients
Mark Kramer is Greenleaf’s primary expert on combination products, providing clients with unique insight from his experience establishing and leading the FDA’s Office of Combination Products (OCP). As Director of OCP from 2002 to 2007, 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 at Greenleaf is informed by his training as a biomedical engineer and a career of more than 35 years in medical product regulation that has united technical, front-line regulatory skills with strategic advising and leadership. He ran 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. Clients further benefited from his knowledge of FDA expectations for key device concerns, such as biocompatibility, electrical safety, electromagnetic compatibility, as well as his biomedical engineering background, which enhanced his reviews of design control documentation for devices and combination products. Mark has also served as an expert witness, testifying in depositions and trials, in a variety of litigation matters and provided regulatory expertise for due diligence activities.
During his 17 years at the FDA, Mark also 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. He managed interdisciplinary review teams as Chief of the Urology and Lithotripsy Devices Branch and as Chief of the Anesthesiology and Defibrillator Devices Branch of CDRH’s Office of Device Evaluation and directed the Center’s education and training programs for staff and industry. Beyond his deep experience at the Agency, Mark 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.
Mark has served as a board member of the Regulatory Affairs Professionals Society (RAPS), and in 2021 was awarded the RAPS Founders Award. He is also a longstanding adjunct faculty member with the Regulatory Affairs Master’s Program at St. Cloud State University (Minnesota). He earned an M.S. in biomedical engineering from Rensselaer Polytechnic Institute in New York and a B.A. in mathematics from Rutgers College of Rutgers University.
Greenleaf was selected by a multinational medical device company to serve as an independent GMP and Medical Device Reporting (MDR) expert. In this role, Greenleaf was made responsible for performing initial audits and procedural reviews at the company’s locations in the U.S. and Asia. Greenleaf’s work started with a review of company policies and procedures; …
Greenleaf Health was invited by a partner at a prominent D.C. law firm to write a chapter on in vitro diagnostics (IVDs) for inclusion in a book to be published by the Food and Drug Law Institute (FDLI). In vitro diagnostics have become an increasingly large part of Greenleaf’s portfolio of regulatory services, furthered by …
Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …
A medical device start-up was involved in a commercial dispute against a large multinational device manufacturer and sought Greenleaf Health’s services as an expert witness and consultant on the FDA regulatory grounds for the case. Greenleaf’s litigation support team prepared an expert report that reinforced the client’s arguments regarding the likelihood that the FDA would …
Greenleaf Health worked with a major orthopedic company to gain marketing authorization for a new formulation of an approved bone augmentation product. Due to the complex regulatory and scientific nature of this project, Greenleaf coordinated with a large team of in-house and external regulatory and scientific experts in order to devise the most advantageous strategy …
Greenleaf Health provided strategic and tactical advice to an early-stage start-up regarding their premarket submissions for a novel wound retraction system after the FDA determined that the company would need to follow the de novo pathway. The Greenleaf team assisted the company with development and submission of a de novo classification request for their product. …
Greenleaf Health worked with a multinational medical device company throughout the review and submission of a breakthrough device designation request for a device indicated for the minimally invasive treatment of lung tumors. The Greenleaf team provided strategic advice on how to frame the device description and indication for the breakthrough request in light of the …
Samantha Eakes
Vice President, Regulatory Affairs
Background:
Public health, public policy, and non-profit sector
Specialty:
FDA regulation of medical devices and combination products | Premarket medical device submissions
Experience:
7+ years of FDA regulatory consulting experience
Samantha brings more than seven years of FDA regulatory consulting experience and a diverse background in public health, public policy, and the nonprofit sector to her position as Vice President of Regulatory Affairs.
Through her public health studies and prior experience, Samantha acquired critical public health knowledge that allows her to effectively assist clients with developing communications and advocacy strategies, stay informed on evolving regulatory requirements, and provide strategic insight on critical regulatory challenges.
In her role at Greenleaf, Samantha advises clients regarding potential FDA regulatory pathways for their devices and assists clients with their FDA submissions and correspondence. She reviews, drafts, and files FDA premarket submissions for medical device clients, including: Pre-Submissions (Pre-Subs); Submission Issue Requests (SIRs); Requests for Designation (RFDs); Breakthrough Device Designation Requests; Investigational Device Exemptions (IDEs); 510(k) Premarket Notifications; Premarket Approval Applications (PMAs); and Emergency Use Authorizations (EUAs). Samantha also conducts research for medical device clients to use in strategic planning and analyzes the regulatory landscape using FDA databases, regulations, policies, and guidance documents.
Samantha has published articles on medical device-related topics such as cybersecurity and the FDA’s least burdensome provisions.
Prior to joining Greenleaf, Samantha gained policy and advocacy experience at Management Sciences for Health (MSH). She also previously volunteered with Arts for Dementia, an organization in London, England, that provides art and music therapy for individuals living with dementia and Alzheimer’s disease.
Samantha earned a B.A. in psychology from Boston University and an M.P.H. from Boston University’s School of Public Health.
