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FDA Encourages Voluntary Device Shortage Reporting After PHE End

 
• By Hannah Daniel

The FDA updated its policies regarding 506J notifications for device manufacturers at the end of the public health emergency.

Due to the severe shortage of medical supplies due to the Coronavirus COVID - 19 outbreak, volunteers and staff are working to produce surgical masks. • Source: InkheartX; Shuttertock.com

The end of the COVID-19 Public Health Emergency ended mandatory reporting of device shortages, but the US Food and Drug Administration encourages manufacturers to continue to alert the agency regardless.

Section 506J of the Food, Drug and Cosmetics Act requires manufacturers to report shortages of critical devices during (or in advance of) a public health emergency

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