The 510(k): Its Purpose, Compilation, and Submission 2014

Key Topics

• FDA`s and EU’s emphasis
• FDA device clearance / approval
• Tracking and evaluating changes the "tipping point"
• Product changes and filing a new 510(k) who`s responsible
• The FDA`s "Decision Tree"
• Is the process "risk based"?
• Resolving a "wrong decision"
• Documenting the process / rationale

Who should Attend

• Regulatory affairs
• Senior management, project leaders, internal / external consultants
• R&D and engineering staff
• Quality systems personnel / QAE
• New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
• Personnel involved in Lean and Six Sigma Initiatives
• CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems