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:

You can contact Michael Drues via email or LinkedIn.