Device Changes, FDA Changes, and the 510(k)
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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 product?
Areas Covered in the Session:
Who Will Benefit:
- 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"
- 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.
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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.