Regulatory Pathways

Created using ChatSlide

This lecture provides a comprehensive overview of regulatory pathways for medical devices and cell therapies, essential for students and professionals in healthcare, technology, and policy fields. Beginning with the foundational understanding of regulatory pathways and their significance, the session delves into the roles of governing bodies like the CDRH in device approval and safety measures. It explores various pathways including 510(k), De Novo, PMA, and Emergency Use Authorization,...