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 FDA has removed N95s respirator masks from its medical device shortage list, citing increased domestic production.
The US agency issued a new draft guidance to require medical device and diagnostics manufacturers and distributors to report supply chain issues in the event of a public health emergency.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.