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.
Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.