Cozen O’Connor: Reviewing the FDA's Perspective on the Ever-Expanding Role of Digital Health

Reviewing the FDA's Perspective on the Ever-Expanding Role of Digital Health

Location

The Bostonian Hotel
26 North St
Boston, MA 02109

 


Date & Time

Start Date: 09/18/2019
End Date: 09/19/2019

Download Calendar Appointment

 

Ryan Blaney will present at the American Conference Institutes' 34th Annual FDA Boot Camp reviewing the FDA's perspective on the ever-expanding role of digital health. The conference will feature distinguished counsel of the Food and Drug bar, who will teach the essential elements of the FDA law and regulation. Ryan's presentation will cover: 

  • Examining the FDA’s Digital Health Innovation Action Plan 
  • Assessing the Digital Health Pre-Cert Program
  • Discussing expected draft guidance on clinical decision support software
  • Distinguishing software that falls under FDA guidance from that which does not
  • When must a 510k be submitted for a software change to an existing device?
  • Reviewing FDA cyber security policies and proper methods to exchange information on digital health