510(k) Modernization, Breakthrough Device, and Safer Technologies Programs (STeP)

This webinar will explore the FDA’s recent initiatives aimed at streamlining the approval process for innovative and safer medical technologies. These include the Medical Device Safety Action Plan and updates to enhance the 510(k) and De Novo review processes, creating more efficient pathways for novel devices to gain FDA clearance or approval.

Additionally, the FDA has introduced two new programs: the finalization of guidance for the Breakthrough Device Program and the development of the Safer Technologies Program (STeP). Both programs focus on 510(k) and PMA pathways, offering less restrictive submission requirements for breakthrough technologies. This shift in the FDA’s approach prompts the industry to rethink submission strategies to take advantage of these new opportunities.

WHY YOU SHOULD ATTEND:

In recent years, the FDA has actively modernized the 510(k) clearance pathway, primarily used for low- to moderate-risk devices that are substantially equivalent (SE) to existing market products. The updates, outlined in the 2018 Medical Device Safety Action Plan, create new opportunities for devices to be cleared more efficiently, especially for breakthrough technologies or safer devices that reduce risks for users. By expanding flexibility for SE comparisons, these pathways allow manufacturers to clear advanced devices without needing to pursue the more demanding De Novo or PMA submissions.

AREAS COVERED IN THE SESSION:

• 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 Draft Guidance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 Q-Sub[mission] Program
• Basic US FDA’s Expectations for the 510(k)

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Everyone involved in the U.S. FDA-regulated medical device (cGMPS) and submission environments. Especially those involved in new medical product / combination product development, line extensions, and incremental product improvements, especially novel technologies.

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.