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?
Webinar Takeaway
- U.S. FDA device clearance / approval
- FDA's and EU's emphasis
- Product changes and filing a new 510(k) - who's responsible
- 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"
Who Will Benefit
- Senior Management, Project Leaders, Internal / External Consultants
- Regulatory Affairs
- Quality Systems Personnel / QAE
- R&D and Engineering Staff
- Personnel involved in Lean and Six Sigma Initiatives
- New product development, Regulatory Submissions, Driving company-wide quality initiatives, under a risk-justified approach
- CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems
Faculty John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Saint George, Utah
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. Mr. Lincoln 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 / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).