Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.
Areas covered in the session: - Create and use a recall operational procedure and what should it contain
- Understand what are effectiveness checks
- What happens in a medical device recall
- Learn why a recall is either a correction or a removal depending on where the action takes place
- Understand what is required for the recall strategy as expected by FDA
- Medical device recall authority and guidance
- Depth of recall and using a viable, sustainable and effective strategy
- Understand why the documentation and paper trail are so critical and termination of a recall
- Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming
Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA`s involvement. The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the recall process from start to finish, including:
- Regulatory Affairs
- Clinical Affairs
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Legal Counsel
- Engineering/Technical Services/Operations
- Consultants
