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FDA Issues Final Guidance On Device Shortage Reporting, Adds Device List

 
• By Brian Bossetta

The US FDA has published final guidance requiring firms to notify the agency about significant manufacturing interruptions of medical devices during a public health emergency, as well as a supplementary draft guidance that includes a list of specific devices that manufacturers must report to the agency when they are in short supply.

Respirators Needed
• Source: Shutterstock

The US Food and Drug Administration has published final guidance it says will help manufacturers provide timely and vital information about production changes of medical devices that can reduce shortages of those devices during a public health emergency (PHE).

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