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FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know

Location: California, USA
From: 2021/07/12 11:00
To: 2021/07/13 12:30
Posted by: WCS Compliance

About this event
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

The FDA is modernizing the 510(k) framework to reflect advances in device technology, safety and capabilities, making it harder to obtain clearance.

If you’re used to basing substantial equivalence on older predicate devices, know this: the FDA now is looking for equivalence to a contemporary baseline of objective safety and performance criteria (think: interoperable, interconnected, more portable, automated, advanced materials…).

Do you know how to keep up with these developments?

Avoid the common mistakes many make with 510(k)s and adjust now to the FDA’s evolving expectations with this webinar.

John E. Lincoln, Principal of J. E. Lincoln and Associates LLC serving as a medical device consultant specializing in regulatory affairs, will explain how to streamline your 510(k) processes and shorten your timeline to clearance. He’ll share current best practices and tips for submitting 510(k)s, the FDA’s changes and how to keep your 510(k)s on track.

Webinar Takeaway
Specific changes the FDA made to the 510(k) process including implications for companies choosing predicates cleared more than a decade ago
How to identify suitable and favourable predicate devices by identifying similar or competitor products and going beyond the premarket comparison
How to determine what type of adverse events are common in your product classification so you can select a predicate with a relatively clean history
How to deal effectively with new challenges, including the possible need for additional testing to reflect post market information for your device classification
How to overcome specific challenges in creating and executing a sufficient test plan, including identifying all of the relevant standards and guidance’s and looking into the most recently cleared devices within your product code
What the best time is to file your pre submission within the development process, and the right questions to ask to gain the most value from your meeting
Understand and use third-party reviewers per the FDA’s new 510(k) Third Party Review Program issued in March
How to stay current and find the latest FDA guidance and enforcement policies
It’s about to become even more of a challenge to obtain 510(k) clearances. Facilitate your 510(k)s and consolidate your timeline.
Who Will Benefit
All Regulatory Affairs Specialists
Any Medical Device Consultants
Biomedical Engineers
Research and Development Engineers
Any Regulatory, Quality and Compliance Professionals
John E. Lincoln
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 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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).

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