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.
"breakthrough technologies" using less restrictive submission requirements / pathways. Such approaches require a rethinking of submission strategies on the part of industry, to benefit from the FDA's changed thinking.
Basic US FDA’s Expectations for the 510(k)
FDA Commissioner’s Statements on Modernizing the 510(k)
The Medical Device Safety Action Plan
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.