Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document. These steps are viewed by the Agency as a top priority, and provide insight into the Agency’s thinking about what a 510(k) could do to advance medical benefits to the patient.
This webinar will evaluate the new steps the FDA expects to see in any 510(k), which 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. The FDA expects to see major changes in this process used by the submitter of a 510(k) going forward. If done right, this will result in a faster review cycle. If done wrong, or not done at all, this would result in unnecessary review delays, and even an RTA from the Agency.
We will discuss key points from the Release Statement, the Draft Guidance, and the Medical Device Safety Action Plan, and how these expectations are to be fulfilled and presented in the 510(k) submission.
A key part of any 510(k) is comparative testing to predicate devices to demonstrate that a new device is substantially equivalent to the predicate. The FDA expects to see major changes in this process, with the ultimate goal of promoting innovation to help patients access safe and effective treatments, and could also help a company improve its competitive position in the market.
A major change is the Agency’s encouragement of “beneficial iteration”, a concept that many companies try to steer clear of in a 510(k) submission. Meeting these Agency expectations will result in a faster review cycle. If they aren’t met, the review cycle will be delayed, or worse, the Agency may issue a Refuse to Accept (RTA).
Knowing this information in advance will ensure proper research is performed, the right examples are chosen, and the desired information is presented properly in the submission.
The webinar will evaluate these changes, what they mean in terms of what the Agency expects to see in a submission, and how a company can supply and present the necessary information in the Traditional 510(k) format.Areas Covered in the Webinar:
Principal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, 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, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.
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Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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