How do FDA Medical device recalls?

 

What is the process of Medical device recalls? 

If the manufacturer or importer fails to recall their product FDA may issue recall order under 21CFR 810. Medical devices recall usually conducted voluntarily. Recall means removing or correcting the product. According to the definition of FDA, 

Recall means a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.  

Recall by classification: 

The FDA will give a recall classification based on this determination, such as Class I, Class II, or Class III, to determine the relative level of health threat of the product being recalled or considered for recall. Types of recall : 

Class 1recall can cause a severe impact on patient’s life, they can lead to death so these products should recalled voluntarily by the manufacturer. The impact of Class 2 devices may or may not be life threatening such as medical  implants, class 3 recall may not likely to cause adverse health consequences . 

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