Revised FDA Guidance Says Makers Of Tests, Hospital Beds, More Should Tell Agency Of Shortages

The US FDA has updated its how-to guide on reporting device shortages during the pandemic with a separate online resource that lists products for which the agency believes notification would be recommended.

FDA entrance sign 2016

Manufacturers of laboratory tests, hospital beds and infusion pumps are among those who should alert the US Food and Drug Administration to device shortages during the COVID-19 pandemic, the agency said in a 19 June revision to a recent emergency guidance document.

The guidance instructs makers of critical products used during the ongoing public health emergency on how to let the FDA know if they’re expecting a disruption in manufacturing or...

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