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Coronavirus Crisis Highlights FDA’s Device Supply Chain Blind Spots

 
• By Shawn M. Schmitt

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.

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The ongoing coronavirus crisis has shone a light on the US Food and Drug Administration’s inability to clearly see medical device supply chain troubles to help stave off product shortages.

That’s because – unlike makers of pharmaceuticals and biologics – there’s no requirement for device manufacturers to tell the agency if there’s a particular event that could lead to a...

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