Mike Ryan

Speaking Session: We Changed One Tiny Itty Bitty Thing… Do We Reaaaaally Need a New 510(k)?

Mike Ryan
Executive Vice President

ELIQUENT

Mike Ryan is a regulatory leader at ELIQUENT Life Sciences, bringing over 21 years of distinguished experience at the U.S. Food and Drug Administration (FDA). Throughout his extensive tenure at the Center for Devices and Radiological Health (CDRH), Mr. Ryan held key senior leadership roles, including Deputy Director of the Office of Regulatory Programs, Director of the Division of ENT, Sleep-Disordered Breathing, Respiratory, and Anesthesiology Devices, and Regulatory Advisor within the Office of Device Evaluation.

Mr. Ryan’s expertise spans the entire Total Product Life Cycle (TPLC), encompassing premarket submissions (such as 510(k)s, De Novos, and PMAs), digital health regulation, quality systems, and postmarket surveillance. He has personally overseen hundreds of submissions, shaped vital agency guidance documents, and driven transformative regulatory initiatives. Recognized for his collaborative leadership and strategic problem-solving, he is a recipient of numerous honors, including the FDA’s highest individual distinction, the Award of Merit.

He holds a Bachelor of Science in Biomedical Engineering from Tulane University.