FDA requires devicemakers to report supply issues during pandemic

The FDA is requiring medical devicemakers to notify the agency of any significant interruptions in the supply chain of certain medical products to prevent or mitigate shortages during the COVID-19 pandemic. 

The agency hasn't previously been able to track medical device shortages, as devicemakers aren't required to report shortages the way drugmakers are. 

But a section of the Coronavirus Aid, Relief and Economic Security Act, or CARES Act, requires manufacturers to tell the FDA of any interruptions in the supply chain of medical devices that are likely to affect U.S. hospitals' ability to treat COVID-19 patients. 

The rule will only be in effect while the pandemic is considered a public health emergency in the U.S., according to the FDA. 

Read the full news release here.


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