Overview: 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 product?Areas Covered in the Session:U.S. FDA device clearance / approvalFDA's and EU's emphasisProduct changes and filing a new 510(k) - who's responsibleTracking and evaluating changes - the "tipping point"Is the process "risk based"?K-97-1 and the FDA's "Decision Tree"Documenting the process / rationaleResolving a "wrong decision"Who Will Benefit:Senior management, project leaders, internal / external consultantsRegulatory affairs Quality systems personnel / QAER&D and engineering staffPersonnel involved in Lean and Six Sigma InitiativesNew product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approachCAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.