Regulatory Approval for Medical Devices

Certificate Short-Course

Course Description

The Food and Drug Administration is responsible for ensuring that medical devices are safe and effective for their intended uses before they are marketed within the US.  This course provides an overview of FDA’s regulatory authority and key amendments to the Food, Drug & Cosmetic Act which govern the approval pathways of medical devices in the US today. Participants will also gain an understanding of the different pathways used by FDA to market safe medical devices, including both the 510(k) and pre-market approval processes. Finally, the types of changes that can impact filings—and the information required by the FDA when changes are made—will be explored.

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Course Type Online (Asynchronous)
Instructor Wayner Williams
Duration 2.5 hours