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

Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions is a webinar that covers topics such as:

  • 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

Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions is intended for:

  • 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

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