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

Date : 20th April 2021 to 20th April 2021

Place : United States, East Camden

Website :https://worldcomplianceseminars.com/

Contact Person:WCs Conference

Description:

This 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. In addition the Agency has further announced two additional device programs: 1) Finalising guidance on the existing Breakthrough Device Program; and 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. Such approaches require a rethinking of submission strategies on the part of industry, to benefit from the FDA's changed thinking.

FDA’s Plan for Modernizing the 510(k) Pathway Live Webinar will be held in East Camden,United States on date 2021-04-20

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Deadline for abstracts/proposals : 20th April 2021

Keynote Speakers : 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.

Conference Highlights :Basic US FDA’s Expectations for the 510(k) FDA Commissioner’s Statements on Modernizing the 510(k) The Medical Device Safety Action Plan The Safer Technologies Program Draft Guidance STeP, and Breakthrough Technologies “Beneficial iteration” and the 510(k) Proper implementation under this 510(k) “Pathway” Meeting expectations before, during and after submission The 21 Elements in a Traditional 510(k) with the new focus

Check the event website for more details.