FDA Medical Device Law Fundamentals

Understanding the unique language and role of the FDA is critical to all health lawyers, particularly those who may represent medical device or healthcare application developers or manufacturers.

In this webinar, our panel of seasoned FDA attorneys will give you an overview of the responsibilities of the FDA and its impact on the medical device and healthcare mobile app approval.

Topics will include:

• An introduction to the FDA and how it’s organized

• The Basics of Device classification and what qualifies as a Medical Device and how that applies to Mobile Apps

• The clinical trial, premarket approval, and 510(k) processes 

Panelists will also define many of the acronyms and terms unique to the FDA. Attendees will come away with an understanding of what the FDA is looking for during the review process, as well as key regulatory requirements relating to labeling, post-market issues, advertising, reimbursement, adverse event reporting and recalls, and enforcement.