Regulatory Overview

The US Food and Drug Administration(FDA) is the regulatory agency with vast jurisdiction. It is a scientific institution rooted in its missions of protecting public health and promoting innovation. For entrepreneurs, approaching the FDA can be daunting. This knowledge article provides an overview of the regulatory process from ideation of an innovative idea to the U.S. market. Obtaining regulatory approval is more than just a hurdle to overcome, the FDA is a valued partner in the innovation process. At this time, scope of the regulatory overview will focus on medical devices.

Step 1 Ideation: What are the Regulations?

Step 2: Determine Your Product Classification

Step 3 Discovery: Device Classification

Step 4: Pre-Clinical and Evidence Gathering

Step 5: Clinical Trial (Drugs) and Pre-market Authorization (Medical Devices)

Step 6: Commercialization & Distribution

Version

• 04.15.2019 Added Regulatory Pathways
• 01.03.2019 Reformat links
• 08.01.2018 Added "Action" links, Revised Ideation Phase
• 02.11.2017 Initial Revision