Course No: PLAS.6020-031; SIS Class Nbr: 13929; SIS Term: 3030
Course Status: Open
Comprehensive and in-depth analysis of US medical device diagnostics development and approval requirements. Detailed analysis of quality assurance issues and regulatory reforms implemented under the Food and Drug Administration. Provides a step-by-step guide through the Center for Devices and Radiological Health (CRDH) investigational device exemptions, premarket approval, 510 (k) application process, and product development protocol and review processes.
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