Modernizing the 510(k) 2021 - FDA’s Plan for Modernizing the 510(k) Pathway Live Webinar

FDA’s Plan for Modernizing webinar will consider the steps the FDA has been taken to provide different and more efficient pathways for novel technologies to receive FDA clearance or approval, e.g., the Medical Device Safety Action Plan, and recent updates to modernize and enhance the 510(k) and De Novo review processes.
2) Plans for a new Safer Technologies Program (STeP). Each addresses one of the two existing pathways , 510(k) and PMA, to address what the FDA calls "breakthrough technologies" using less restrictive submission requirements / pathways.
The Medical Device Safety Action Plan
The Safer Technologies Program
Draft Guidance STeP, and Breakthrough Technologies
Speaker:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 39 years experience in U.S. FDA-regulated industries, 25 of which are as an independent consultant.