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RAS 623. Regulatory Routes to Market: 510(k)s

Credits: 3
Department: Regulatory Affairs
Description: U.S. route to market for medical devices, the Premarket Notification of 510(k), and regulation and requirements. Best practices associated with the preparation and clearance of Premarket Notifications. Developing regulatory strategies for markets.
Prerequisites: RAS 621
Semester Offered: DEMAND
Grading Method: ABCDF

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