Medical Device Recalls 2015

Key Topics

• How to determine if you have a Medical Device Recall
• What is a Recall?
• Things to Consider When Recalling Your Medical Device
• What can FDA do when a firm is reluctant to conduct a recall?
• Where and What Should Be Reported?
• Who can initiate a Medical Device Recall?
• FDA Role and Expectations
• Reports of Correction and Removal
• FDA`s Enforcement Policy on recalls
• Company Responsibilities for a Recall
• Safety Alerts
• Adverse Consequences or Health Risk Evaluations
• Follow-up Responsibilities (FDA and Company)
• Recall Strategy and Communications
• Recall Classification
• Quality System Requirements
• Recall Termination
• Recall Status Reports

Who should Attend

• Managers to Senior Directors in Reg. Affairs, QA, Clinical Research, and Data Monitoring
• Clinical Trial Physicians and Professionals
• Small business owners
• Institutional Review Boards