Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions 2019

Topics

• Pre-Submission Interaction
• FDA`s Guidance on Refuse to Accept
• The 510(k) Checklist
• 510(K) Refuse to Accept Policies and Procedures - High Level
• Notification of Acceptance Review Result
• FDA Review Clock
• Refuse to Accept Checklist - Details
• Refuse to Accept Principles - Details
• Traditional vs Non-Traditional 510(K)s
• Acceptance Review Checklist - Details

Who should Attend

• Clinical Trial Physician / Doctor
• Regulatory Personnel
• Regulatory Affairs
• Manager to Senior Director / VP of
• Clinical Research
• Quality Assurance
• Data Monitoring
• Data Management
• IT
• Institutional Review Board