Device Changes, FDA Changes, and the 510(k)
September 9, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
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" Compliance4All Adam Fleaming Phone: +1-800-447-9407 support@compliance4all.com www.compliance4all.com http://www.compliance4all.com/control/w_product/~product_id=500444LIVE/