FDA Cobbles Together Pilot For Remote Review Of Manufacturer Records
The coming pilot program would give the US FDA remote access to a manufacturer’s records. It’s another approach the agency wants to try as it feels out the best way to virtually evaluate regulatory compliance during the COVID-19 pandemic.
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The US FDA is assessing via a pilot program whether the use of video is helpful when investigators perform remote facility inspections. Meanwhile, the agency’s device center is “working on alternative approaches for assessing a firm’s quality management system,” an FDA official says.
The COVID-19 pandemic is nudging the US FDA to launch a voluntary pilot program that will allow agency investigators to conduct facility inspections virtually, King & Spalding’s Steve Niedelman said on 11 November.
The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.