With New Guidance, FDA Says Makers Of Critical Devices Must Report Manufacturing Or Supply Chain Disruptions
Manufacturers of life-supporting and -sustaining devices – and other critical products used during the ongoing COVID-19 public health emergency – must let the US agency know if they’re expecting a disruption in manufacturing or supply. A new immediately-in-effect guidance document from the FDA explains how.
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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.