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