FDA's Evolving Approach to Medical Device Reviews – FDA Watch
Wayne chats with Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You’ll hear their thoughts on where the relationship between FDA and the device industry stands right now; factors that influence how reviewers assess risk, credibility, and readiness during submission reviews; the role of the TPLC approach at CDRH; FDA’s elimination of the requirement that RWE submissions include identifiable patient-level information; practical changes sponsors can make to improve regulatory outcomes, without increasing time or cost; and much more.
Headlines
Pharma: FDA outlines new “more flexible” approach to CMC requirements for cell and gene therapies
Devices: FDA publishes two final guidance documents clarifying wearable and AI-enabled device oversight
Food: FDA Commissioner Makary chats about new food pyramid on NPR’s All Things Considered
Cosmetics: U.S. Rep. Randy Weber introduces PACK Act
Resource Links
Devices: CounterPunch op-ed, “The FDA Fails to Protect Americans from the Medical Device Industry”
Food: FDA opens Voluntary Qualified Importer Program
Cosmetics: Report on the Use of PFAS in Cosmetic Products and Associated Risks
About Our Guests
Mike Ryan
Mike Ryan brings a rare combination of regulatory depth and strategic vision to his role as Executive Vice President. With over 21 years of experience at the U.S. Food and Drug Administration, Mike has worked across the full regulatory spectrum — premarket review, compliance, postmarket surveillance, and policy development — giving him a truly comprehensive view of the medical device landscape.
During his tenure at FDA, Mike served as a lead premarket reviewer and a Total Product Life Cycle (TPLC) manager across multiple product areas. He played a central role in modernizing regulatory processes as a regulatory advisor and senior leader in CDRH. His contributions include reviewing and overseeing hundreds of premarket submissions, developing dozens of regulations and guidance documents, and leading continuous improvement and transformative initiatives in compliance and postmarket surveillance.
Mike is widely recognized for his collaborative approach, clear communication, and ability to navigate complex regulatory and organizational challenges. He excels at strategic problem solving and is especially passionate about advancing innovative medical products that address areas of unmet need, ensuring patients benefit from the best science and technology have to offer.
Michael Gaba
Michael Gaba provides strategic FDA regulatory, Medicare policy, and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations, or pharmaceuticals. His primary goal is to bring companies to market and then help them remain there in the most efficient and effective manner possible.
Working as an extension of each company’s legal and business teams, Michael draws on nearly 30 years of experience to navigate the FDA pre-market regulatory pathways, counsel companies on FDA post-market compliance matters, and resolve Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services. By using his FDA and CMS experience during the product development phase, Michael is able to help maximize companies’ opportunities to be appropriately compensated in the proper treatment venues, whether a physician’s office, hospital outpatient or inpatient departments, ambulatory surgical centers or home care.
During the COVID-19 pandemic, Michael provided strategic FDA counsel to many medical device and diagnostic companies, including several first-time entrants to the medical device space, helping them obtain emergency use authorizations from the FDA, and advising them on how to comply with FDA’s pandemic-focused enforcement discretion policies. Michael continues to advise these companies on transitioning to full FDA compliance in the post-pandemic environment.
There are times when federally-regulated life science companies and the patients they serve would benefit from changes to public policy, Michael works with members of Congress and Executive Branch officials to develop, enact and implement these policy changes.
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