Success Stories

Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.

Helping a Digital Therapeutic Client Successfully Navigate the De Novo Regulatory Pathway

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

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 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. 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 benefitted 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. 

Kate Cook

Principal, Regulatory Policy

Kate Cook joined Greenleaf following a distinguished career of more than 20 years with the U.S. Food and Drug Administration (FDA). During her FDA tenure, Kate provided crucial direction on strategic initiatives related to the regulation of drugs, biological products, and medical devices. Kate continues her commitment to public health at Greenleaf as Principal, Regulatory Policy, providing strategic consulting services and working with clients to bring innovative medical products to patients.

Kate’s FDA career began in the Office of the Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to biosimilars, gene therapy, vaccines, allergenics, human tissue and cellular products, blood products, medical devices, and combination products. She also provided guidance on human subject protection and advertising and promotion. Kate went on to serve as Associate Director for Regulations and Policy within the FDA’s Center for Devices and Radiological Health (CDRH), where she led strategic development and implementation of policies and regulations applicable to medical devices and radiation-emitting products. Later, as Senior Advisor in the FDA’s Center for Biologics Evaluation and Research (CBER), she played a pivotal role in the development and implementation of regulations and regulatory policy related to biological products, combination products, and medical devices regulated by CBER.

From 2016 to 2021, Kate was Executive Vice President with Greenleaf’s Drug and Biological Products Team. In 2021, she was enlisted to support the federal government’s pandemic response efforts. She returned to Greenleaf as Principal, Regulatory Policy, and now leads the firm’s services focused on supporting clients with expertise and guidance on FDA regulatory policies and programs.

Kate is the recipient of numerous FDA awards, including the FDA Award of Merit, the Secretary’s Award for Distinguished Service, the Commissioner’s Special Citation, and the CDRH Director’s Special Citation.

A graduate of Swarthmore College, Kate received her law degree from the New York University School of Law. 

Medical Device Auditing and Certification for Compliance with FDA Guidelines

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; …

Contributing a Chapter on In Vitro Diagnostics to an FDLI Book Publication

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 …

Conducting Due Diligence to Guide a Corporate Acquisition Decision

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 …

Providing Litigation Support That Led to a Favorable Judgment for a Device Start-Up Firm

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 …

Collaborating to Streamline Review of a Complex PMA Submission

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 …

Planning and Supporting a Regulatory Strategy for De Novo and 510(k) Submissions

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. …

Achieving a Breakthrough Device Designation

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 …

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