The FDA 510(k) and Q-Submission: Best Practices 2015

Topics

• Definitions
• Statute(s) And Regulations
• 510(k) Program
• Device Classification And Predicates
• Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
• When 510(k)s Are Required
• Substantial Equivalence: Factors to Consider and Special Considerations
• Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
• Applicable Standards and Guidance
• Addressing e-Copy And RTA Policy Requirements
• Common Pitfalls and How to Prevent Them
• 510(k) Contents And Format
• Responding to FDA`s Request of Additional Information.
• What to Ensure While Preparing Your Q-Submission and a 510(k) Application
• Best Practices for a Q-submission
• Resolving Different Opinions and Interpretations
• Speaker`s Practical, Actionable and Sustainable Solutions
• Best Practices for a 510(k) Preparation, Submission and Clearance

Who should Attend

Senior attendees involved or interested in:

• Regulatory Affairs
• Quality Assurance
• Research & Development
• Quality System Management
• Quality Control
• Consultants
• CROs
• Senior management
• Contractors/Subcontractors
• Anyone interested in 510(k) matters