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.
A $2.2tn coronavirus stimulus package signed into law by President Trump on 27 March will distribute billions of dollars to federal agencies – including the FDA, the CDC and the FEMA – to hasten approvals of new diagnostics, medical ventilators, respirators and other medtech supplies, conduct more testing of potential COVID-19 patients, and quickly distribute medical supplies where needed most.
The ongoing COVID-19 crisis has shone a light on the US agency’s inability to clearly see medical device supply chain troubles to help stave off product shortages. Unlike makers of pharmaceuticals and biologics, there’s no requirement for device firms to tell the FDA if there’s a particular event that could lead to a shortage – but that could change thanks to language found in the agency’s fiscal year 2021 budget request.