FDA Guidance: Medical Device Recalls

This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.

Why Should You Attend:

Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly can lead to seizure, multiple seizures or other court action by the FDA. Effective recalls will minimize both the financial and PR issues for your firm, and will enable your firm to swiftly move to the phase of starting to re-build after an issue.

This webinar will discuss FDA guidance on medical device recalls.

Areas Covered in the Webinar:

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

Who Will Benefit:

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