Device Changes, FDA Changes, and the 510(k)

from Compliance4all

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 / 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

Speaker Profile
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. (from )

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