The 510(k) Mod Program, Breakthrough Technologies, and STeP

Description

This webinar will consider the steps the FDA has been taken to provide different and more efficiant pathways for novel or safer 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) Finalizing 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.

Why Should You Attend:

Over the past few years, the FDA has been developing new approaches to modernize FDA’s 510(k) clearance pathway, used for low- to moderate-risk devices that are substantially equivalent (SE) to a device already on the market, known as a predicate device. These changes include new pathways for these devices that the FDA has laid out and discussed in their Medical Device Safety Action Plan, issued April 16, 2018. The 510(k) pathway is used for the majority of devices that the FDA reviews.

Manufacturers often rely on comparative testing to predicate devices to demonstrate that a new device is substantially equivalent to the predicate. These new pathways expand the leeway for SE matches / comparisons, to allow for the clearance of "breakthrough technologies" or safer devices that pose reduced risks to the users, without having to go the De Novo or PMA submission route.

Areas Covered in the Webinar

• 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 Draft Guidance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 Will Benefit:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel 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.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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