If a medical device is approved for marketing outside the US and is requested to be returned before shipment, what is this process called?

If a medical device is approved for marketing outside the US and is requested to be returned before shipment, what is this process called?

• A. Market withdrawal
• B. Stock recovery
• C. Class I recall
• D. Class III recall

Answer: (B)

The process of requesting the return of a medical device that has been approved for marketing outside the US before it is shipped is referred to as stock recovery. This term specifically relates to the action of retrieving products that have not yet been distributed to end users or health care facilities, ensuring that these products do not enter the market for any potential safety or compliance concerns. In this context, stock recovery serves as a proactive measure to manage any risks associated with products before they reach consumers. It is an important aspect of regulatory compliance and risk management in the broader category of medical device regulation. Regarding the other options: market withdrawal usually implies that the product is being removed from the market entirely, requiring a more extensive process. Class I and Class III recalls pertain to devices already distributed and involve the removal of products from the market due to serious health risks or violations of regulatory standards, which is not applicable in a scenario where the product has not yet been shipped.

The process of requesting the return of a medical device that has been approved for marketing outside the US before it is shipped is referred to as stock recovery. This term specifically relates to the action of retrieving products that have not yet been distributed to end users or health care facilities, ensuring that these products do not enter the market for any potential safety or compliance concerns.

In this context, stock recovery serves as a proactive measure to manage any risks associated with products before they reach consumers. It is an important aspect of regulatory compliance and risk management in the broader category of medical device regulation.

Regarding the other options: market withdrawal usually implies that the product is being removed from the market entirely, requiring a more extensive process. Class I and Class III recalls pertain to devices already distributed and involve the removal of products from the market due to serious health risks or violations of regulatory standards, which is not applicable in a scenario where the product has not yet been shipped.