IMDRF 2023

Cassie Scherer is the Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic. In her position, she leads global policy work relating to digital health technology, including AI/ML-enabled products, as well as U.S. FDA regulatory policy work. Cassie is one of the GMTA industry representatives for the IMDRF SaMD Working Group and also co-leads with FDA the Digital Health Initiative at the Medical Device Innovation Consortium (MDIC) that focuses on collaboratively and strategically advancing regulatory science for digital health technologies.

Before Medtronic, Cassie was Special Counsel at a law firm providing strategic regulatory counsel to medical device and digital health companies. Cassie’s practice focused on premarket review, compliance with FDA’s pre- and post-market requirements relating to medical devices and FDA jurisdictional issues. Cassie also served at U.S. FDA where she was Associate Chief Counsel in FDA’s Office of Chief Counsel and Director of Strategy and Regulatory Operations in CDRH’s Office of Center Director. While at FDA, Cassie advised and consulted on a broad range of matters relating to emerging medical device issues, responding to Congressional inquiries, implementing legislation relating to medical devices, reviewing premarket appeals of regulatory decisions made by FDA, and developing regulations and key FDA guidance documents.