Compliance Professionals 2021 - FDA’s Plan to Modernize the 510(k) Pathway Webinar What Regulatory, Quality and Compliance Professionals Need to Know

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…).
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.
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
Speaker:
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.