Mike Drues

In this insightful discussion, regulatory affairs expert Mike Drues shares his expertise on transitioning medical devices from prescription (Rx) to over-the-counter (OTC). He reveals what triggers new submissions and emphasizes the vital role of usability testing for lay users. Drues elaborates on the risk management challenges posed by removing healthcare providers from the process and the implications of real-world evidence for FDA approvals. Listeners gain practical insights into navigating FDA interactions and aligning regulatory strategies with business goals.