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FDA Issues Final Guidance For Reporting Medical Device Shortages During Emergencies

 
• By Brian Bossetta

The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.

After the COVID-19 pandemic revealed the US was woefully lacking in essential supplies, such as masks, gloves, gowns, and respirators, Congress mandated device makers keep the Food and Drug Administration informed of device shortages during a public health crisis.

Specifically, the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, of 2020 added section 506J to the FD&C (Food, Drug and Cosmetics) Act, requiring manufacturers to report shortages of

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