FDA Guidance: Medical Device Recalls 2014

Key Topics

• Who Can Initiate a Medical Device Recall?
• What Is a Recall
• Where and What Should Be Reported
• How to Determine If You Have A Medical Device Recall
• Firm’s Responsibilities for a Recall
• Reports of Correction and Removal
• Adverse Consequences or Risk to Health
• FDA’s Enforcement Policy
• Firm’s Recall Communication
• Safety Alerts
• Firm’s Follow-up Responsibilities
• Firm’s Recall Strategy
• Things to Consider When Recalling Your Medical Device
• Quality System Requirements
• FDA Expectations
• Recall Status Reports
• Recall Classification
• FDA’s Role
• Recall Termination
• What Can FDA Do When A Firm is Reluctant to Conduct A Recall?

Who should Attend

• Quality Assurance Managers
• Regulatory Affairs Personnel
• Biostatisticians
• Clinical Investigators
• Data Monitors
• Institutional Review Boards
• Data Management Professionals
• Clinical Trial Physician / Doctor
• Data Monitoring Committees