The FDA 510(k) and Q-Submission: Best Practices 2015 covers topics such as:
- 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
The FDA 510(k) and Q-Submission: Best Practices 2015 brings together 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
