This is a past event.
Device Changes, FDA Changes, and the 510(k)-2019
Overview:
Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based?
Areas Covered in the Session:
Is the process "risk based"?
K-97-1 and the FDA's "Decision Tree"
Documenting the process / rationale
Resolving a "wrong decision"
