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.
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.
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Statements on Modernizing the 510(k) The Medical Device Safety Action Plan The Safer Technologies Program Draft Guidance STeP, and Breakthrough Technologies “Beneficial iteration” and the 510(k) Proper implementation under this 510(k) “Pathway” Meeting expectations before, during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
Who Will Benefit
Medical device companies
Regulatory affairs specialists
Medical device consultants
Research and development engineers
John E. Lincoln (33+ year exp.) Medical Devices / Regulatory Consultant; also pharma and dietary supplements Saint George, Utah 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. John has worked with global companies to resolve regulatory issues, lead validations (hardware and software) and implement QMS/RA systems. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide. John is a graduate of UCLA.