FDA Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.
Recalls may be undertaken voluntarily and at any time by manufacturers and distributors, at the request of the FDA or by a mandatory recall order from FDA. Recall requests and orders by the FDA are reserved for urgent situations and are to be directed to the firm that has primary responsibility for the manufacture and marketing of the device that is to be recalled.
Why Should You Attend
Recalling medical devices that present a hazard to consumers supports public health safety and protects companies from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly can lead to seizure actions by the FDA or other court actions. Effective Recalls will minimize both the financial and public relations issues for your company and will enable you to move beyond the effects of a recall much more quickly.
Areas Covered in the Session
• What is a Recall and how to determine if you have one?
• Things to Consider When Recalling Your Medical Device
• Adverse Consequences or Risk to Health
• Who can initiate a Medical Device Recall?
• Where and What Should Be Reported?
• Reports of Corrections and Removals
• Company’s Responsibilities for a Recall
• Company’s Recall Communications, Strategy and follow-up responsibilities
• Quality Control Program
• Recall List
• Recall Status Reports
• Recall Termination
• FDA Compliance policy guide’s
• FDA’s Role and Expectations
• What can FDA do when a firm is reluctant to conduct a recall?
• Safety Risk Management
• How to identify, initiate, and manage a recall action effectively
• What FDA requires for recall reporting
• How FDA classifies and monitors recalls
• What authority FDA can use to force a recall and ensure it is managed effectively
Who Will Benefit
• Regulatory Affairs Managers / Senior Directors
• Quality Assurance Managers / Senior Directors
• Clinical Research Managers / Senior Directors
• Data Management Personnel
• Data Monitoring Personnel
• Clinical Trial Physicians
• Institutional Review Boards
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