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 will provide an overview of the 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 the 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.
Participants in this course will learn:
• An overview of the FDA's regulatory authority
• Key amendments of the FD&C Act
• Pathways to approval for medical devices
• The role of management in implementing cGMPs
• FDA requirements for changes
This course is available online, and can be taken anytime, anywhere.