FDA’s Plan for Modernizing the 510(k) Pathway – Meet the New Expectations

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 This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document.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.

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.

Why You Should Attend:

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We will discuss key points from the Release Statement, the Draft Guidance, and the Medical Device Safety Action Plan, and how these expectations are to be fulfilled and presented in the 510(k) submission.

Frequently Asked Questions:

  • For 510k, can demonstration of equivalence be done with a predicate that is no longer marketed?
  • Are there any special recommendations for nanoparticles-based devices?

Areas Covered in the Session :

  • Basic U.S. FDA’s expectations – the 510(k)
  • What is the FDA “thinking”
  • FDA’s Commissioner’s Statement on Modernizing The 510(k) Pathway
  • The Medical Device Safety Action Plan
  • The Safer Technologies Program for Medical Devices Draft Guidance Document
  • What does the FDA mean by “beneficial iteration” and its role in the 510(k)
  • Proper implementation in view of the current FDA documents
  • What needs to be done before, during and after the 510(k) review process
  • Important and required pre-submission, submission and post-submission actions.

Who Should Attend:

  • Senior and middle management
  • Quality Assurance
  • Regulatory Affairs
  • Compliance
  • Research and Development
  • Engineering
  • Staff and Line personnel
  • Operations / Production
  • Regulatory consultants


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.

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