Selecting The Best Regulatory Path For Your Medical Device

Most new medical devices enter the U.S. market through either the FDA’s 510(k) (premarket notification) or PMA (premarket approval) pathways. However, numerous other options are available, and shrewd device makers will consider all of them in developing a regulatory strategy. In this podcast, Jim Pomager, executive editor of Med Device Online, discusses each of the available paths — including some little-known and little-used ones — with Michael Drues, Ph.D., long-time regulatory consultant and Med Device Online guest columnist.

Additional resources:

• Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel [online course]
• De Novo Path to Device Approvals: Tips for Speedy, Successful Outcomes [online course]
• Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It? [article]
• Secrets Of The De Novo Pathway, Part 2: Is De Novo Right For Your Device? [article]

You can contact Michael Drues via email or LinkedIn.