Duration: 90 Minutes


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The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety/effectiveness, or when a series of lesser changes finally reach the “tipping point”.

  • This is a major headache.
  • How can companies make that determination?
  • How can they trigger such an analysis over the major change or the series of smaller changes?
  • What approaches are required for product changes; for process changes? How is the process risk-based?
  • How to maximize the process against scarce resources?
  • What are the different considerations for CE-marked products?

Areas Covered in the Session : 


This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA’s current Guidance on 510(k) Device Modifications. This session will cover:

  • Deciding When to Submit a 510(k) for a Change to an Existing Device
  • How to provide tools to document such decisions
  • U.S. FDA device clearance / approval
  • FDA’s and EU’s emphasis
  • Product changes and filing a new 510(k) – who’s responsible
  • How to structure a decision matrix to document change decisions
  • Tracking and evaluating changes – the “tipping point”
  • Is the process “risk based”?
  • K-97-1 and the FDA’s “Decision Tree”
  • Documenting the process / rationale
  • Resolving a “wrong decision”
  • Preparing for further 510(k) changes in the future

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Production Departments
  • Research & Development Departments
  • Engineering Departments
  • Lean & Six Sigma staff
  • New Product Development
  • Mid-level and Senior Management
  • Project Leaders
  • Consultants

Course Director: 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.