The US Food and Drug Administration Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
This course discusses the FDA's regulatory authority for approving medical devices prior to marketing and the compliance programs used during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections.
This course gives an overview of the regulations and policies set by the FDA for the pre-market approval, manufacture and post-marketing compliance of medical devices. The course will provide an understanding of the paths to obtaining agency approval, the type of controls, systems and documentation they expect to see in place, how the FDA performs inspections, and the variety of outcomes from each inspection.
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