A medical device 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 are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.
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. The FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.
Helping understand the dynamics of a medical device recall
A webinar is being organized by Compliance4All, a very well-known provider of professional trainings for all the areas of regulatory compliance to explain the nuances of medical device recalls and how to handle them. This webinar will provide valuable and important 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 the FDA’s involvement.
David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services, will be the speaker at this highly educative webinar session. To derive the benefit of this training, please register by logging on to http://www.compliance4all.com/control/w_product/~product_id=500838
Various situations in which recalls are mandated
This webinar will explain the intricacies of a medical device recall. A medical device recall does not always mean that the manufacturer must stop using the product or return it to the company or that it needs to necessarily be removed. It can sometimes mean that the medical device needs to be checked, adjusted, or fixed.
Sometimes, a recall could happen depending on the particular situation, such as in the case of an implanted device such as a pacemaker or an artificial hip. This webinar will explore these possibilities.
The speaker will cover the following areas at this webinar:
o Create and use a recall operational procedure and what should it contain
o Understand what are effectiveness checks
o What happens in a medical device recall
o Learn why a recall is either a correction or a removal depending on where the action takes place
o Understand why is required for the recall strategy as expected by FDA
o Medical device recall authority and guidance
o Depth of recall and using a viable, sustainable and effective strategy
o Understand why the documentation and paper trail are so critical and termination of a recall.