New FDA Webform Makes It Easier For Device Makers To Report Shortages
The US agency on 3 August said the webform should be used by manufacturers to report shortages of products deemed critical to fighting the ongoing COVID-19 pandemic.
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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.
The US agency’s shortage list of critical medical devices needed during the COVID-19 public health emergency has been met with shrugs by two former agency officials, who say the statutorily mandated online listing offers limited value.
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