Revised FDA Guidance Says Makers Of Tests, Hospital Beds, More Should Tell Agency Of Shortages
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.
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The US agency issued a new draft guidance to require medical device and diagnostics manufacturers and distributors to report supply chain issues in the event of a public health emergency.
The US agency says in the latest update to its medical device shortages guidance doc that it’ll send enforcement missives to companies that don’t notify the agency of a “permanent discontinuance or an interruption in manufacturing” of products deemed critical during the COVID-19 pandemic.
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.