Dr. Michael "Emeritus" Marcarelli, PharmD, MS
Former Director of FDA CDRH's Division of Bioresearch Monitoring (BIMO) and head of the Investigational Device Exemption (IDE) program. 35+ years of experience guiding medical device programs through clinical investigations, compliance oversight, and high-stakes FDA decision-making.
Dr. Michael Marcarelli brings deep expertise in FDA regulatory policy, bioresearch monitoring, and clinical investigation oversight, informed by senior leadership roles within the Agency. He has advised on regulatory strategy, compliance risk, and clinical research execution; particularly for programs navigating complex Investigational Device Exemption (IDE) requirements and scrutiny around sponsor and investigator conduct.
Areas of Focus / Expertise
- FDA clinical investigation oversight and IDE program strategy
- Bioresearch Monitoring (BIMO) and inspection readiness
- Regulatory compliance, enforcement, and risk mitigation
- Sponsor and investigator responsibilities and oversight frameworks
- FDA policy interpretation and regulatory decision-making processes
- Clinical trial governance and audit preparedness
- Strategic advisory for high-risk and high-visibility programs
Selected Experience & Impact
Over the course of his career, Dr. Marcarelli served as Director of FDA CDRH’s Division of Bioresearch Monitoring and led the Agency’s Investigational Device Exemption (IDE) program, shaping oversight of clinical investigations and regulatory compliance across the medical device industry. Across more than three decades at FDA and DEA, he contributed to enforcement, policy development, and regulatory operations that directly influenced how the Agency evaluates clinical research and manages compliance risk.
Background & Credentials
Prior to FDA Partners, Dr. Marcarelli held senior leadership roles within the U.S. Food and Drug Administration and the Drug Enforcement Administration, overseeing bioresearch monitoring, IDE program operations, and regulatory compliance initiatives. He holds a BS in Pharmacy from Northeastern University, a PharmD from the University of Arkansas, and an MS in Regulatory Science from Johns Hopkins University.
Dr. Marcarelli provides emeritus-level strategic counsel grounded in firsthand FDA leadership experience, helping organizations anticipate Agency expectations and navigate complex regulatory challenges with clarity and discipline.