Alex Cadotte

Speaking Session: Don't be Predetermined to Fail: PCCP Best Practices for Idiots

Alex Cadotte
VP, Head of Digital Health, AI, and Radiology Regulatory Affairs

MCRA, an IQVIA business

Dr. Alex Cadotte specializes in regulatory strategy for medical devices, with particular expertise in medical device software, Software as a Medical Device (SaMD), Artificial Intelligence/Machine Learning (AI/ML), Clinical Decision Support, Predetermined Change Control Plans (PCCPs), and computer-aided detection, diagnosis, triage, and notification technologies. His consulting work includes FDA regulatory strategy and interactions, development of regulatory submissions, clinical trial design, evaluation of preclinical and clinical data, medical and regulatory writing, and regulatory review of marketing materials.

Prior to consulting, Dr. Cadotte served at FDA as Team Lead for Imaging Software Review, where he led a multidisciplinary team responsible for the regulation of imaging software devices, including AI/ML-enabled devices. He previously served as a Health Scientist and Team Lead in Digital Health, working on software review and FDA’s Pre-Certification Program. He also contributed to CDRH’s AI/ML Working Group, including development of FDA’s proposed regulatory framework for modifications to AI/ML-based SaMD and its AI/ML SaMD Action Plan. Dr. Cadotte holds M.S. and Ph.D. degrees in Biomedical Engineering from the University of Florida.