When And How To Interact With The FDA

Michael Drues, Ph.D., president of Vascular Sciences and author of the Guerilla Regulatory Strategy article series, has spent his entire career communicating with FDA, both as a regulatory consultant for manufacturers, and as an advisor to the agency. In this podcast, he joins Med Device Online editor Jim Pomager to talk about when medical device manufacturers should interact with FDA, what mechanisms available to facilitate such interactions, and how they can best utilize them.

Additional resources:

• FDA Pre-Sub Meetings for Medical Devices – Make The Most Of Your Opportunity [online course]
• How To Make The Most Of Your Pre-Submission Interactions With FDA [article]

You can contact Michael Drues via email or LinkedIn.