Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission 2015

Topics

• Definitions
• Laws and Regulations
• 510(k) Program
• Device Classification and Predicates
• Applicable Regulatory Requirements
• When are 510(k)s Required
• 510(k) Requirements, Contents and Format
• Q-Submission and How to Effectively Use It
• Addressing e-Copy and RTA Policy Requirements
• Substantial Equivalence: Factors to Consider and Special Considerations
• Common Mistakes and How to Prevent Them
• Applicable Standards and Guidance
• Responding to FDA’s Request of Additional Information
• De Novo Process Pursuant to FDASIA 2012
• Best Practices for a Q-submission; 510(k) Preparation, Submission and Clearance
• Resolving Different Opinions and Interpretations
• Conclusions
• Speaker’s Practical, Actionable and Sustainable Solutions

Who should Attend

• R&D
• RA
• CROs
• QA/QC/QS
• Contractors/subcontractors
• Consultants
• Anyone interested in 510(k) matters
• Senior management