Medical Device Regulation - Establishment Registration and Device Listing

In this video, I provide a basic overview of FDA’s medical device registration and listing requirements. We’ll cover the key concepts manufacturers and other medical device companies should understand, including when registration and listing are required, who is responsible for completing the process, and the basic information that must be submitted to FDA. This video is intended as a general introduction for entrepreneurs, medical device companies, regulatory professionals, and others who are looking to better understand FDA’s registration and listing framework. For more information about FDA regulatory requirements for medical devices, visit vanderietlaw.com.