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With New Guidance, FDA Says Makers Of Critical Devices Must Report Manufacturing Or Supply Chain Disruptions

 
• By Shawn M. Schmitt

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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Makers of life-supporting and -sustaining devices – and other critical products used during the ongoing COVID-19 public health emergency – must let the US Food and Drug Administration know if they’re expecting a disruption in manufacturing or supply.

That’s according to a new immediately-in-effect guidance document from the agency that explains how manufacturers should comply with Sec. 506J of the Federal Food, Drug and Cosmetic Act.

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