On-Demand Catalog

All sessions average between 60 and 90 minutes.

Origins and Overview of Drug Law Regulation: An Introduction
Stabilizing After the Stabilization Period: What to Expect From Further Implementation of DSCSA
International Issues for Medical Device Manufacturers: An Introduction
An Introduction to the Regulation of Promotion and Advertising for Medical Devices
FDA Authorities and Processes for the Enforcement, Compliance, and Inspection of Medical Devices
Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction
Post Marketing Issues for Medical Devices: An Introduction
An Introduction to Coverage, Coding, and Payment of Medical Devices – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Medical Device Premarket Approval Applications (PMA); Humanitarian Device Exemption (HDE) and Breakthrough Devices: An Introduction
An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests

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