Medical Device Recalls
When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place.
US FDA defines “Recall”:
Correction - Addresses a problem with a medical device in the place where it is used or sold.
Removal - Addresses a problem with a medical device by removing it from where it is used or sold.
FDA uses the term “recall” when a manufacturer takes a correction or removal action 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.
(Cited from FDA website “What is a Medical Device Recall?”).
All stakeholders involved in the recall process must have provisions to address the issues in a timely manner. The recall process must be handled with adequate care to reduce various risks of the device in question. The process also must be handled with regulatory knowledge and experience in order to avoid serious consequences from mishandling the recall. The recall activities must be reported to regulatory authorities and the effectiveness of the recall must be evaluated.
If your company does not have any procedures for recalls, it will impose major disadvantages.
Do you have a Recall Procedure prepared?
KBC support you in developing the procedure and also actual recall activities.
We cover US FDA and EU recall.