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Medical device recalls are initiated when a medical device is defective, poses a risk to health, or both. The medical device manufacturer is generally charged with voluntarily initiating a recall; however; if the manufacturer fails to act, regulatory authorities, such as the Food and Drug Administration (“FDA”), may directly initiate a recall. While the FDA has rarely exercised its authority to order a medical device recall, the FDA provides general oversight of a medical device recall once it is initiated by the manufacturer.
The FDA categorizes medical device recalls in the following three classes:
Most medical device manufacturers will never have to manage a medical device recall; however, all medical device manufacturers should be prepared to do so. There is a direct link between a successful medical device recall and how well the manufacturer prepared in advance of the recall. The worst time to develop a recall action plan is after a recall is initiated.
When developing a medical device recall action plan, include provisions for the following:
Successfully managing a medical device recall is not an easy task. The chances of success are greatly increased by advance planning for a recall.
This article is not intended as legal advice and does not constitute legal advice. It does not create an attorney/client relationship and is intended to provide only general, educational, non-specific legal information. It is not intended to cover all the issues related to the topic discussed. The specific facts that apply to various situations may make the outcome different than would be initially anticipated. You should consult with an attorney familiar with the issues and laws of your state and country, if you have any legal questions or concerns.
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