Top FDA Official: Agency ‘Creative,’ ‘Efficient,’ ‘Focused’ After COVID-19 Domestic Inspection Hiatus
William Maisel says FDA investigators are putting their best foot forward when conducting facility inspections amidst the coronavirus pandemic.
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‘What, Me Worry?’: Experts Say They’re Not Concerned About FDA Restarting Domestic Inspections Amidst COVID-19
In a few days the US FDA will fire up its domestic inspectorate for the first time since March. But is it a good idea? Three industry experts said during a Food and Drug Law Institute webinar that they’re not particularly worried.
US FDA commissioner Stephen Hahn said on 10 July that the agency has a plan to send investigators back into the field in 10 days. Whether or not a company is inspected, however, will depend on local COVID-19 conditions.
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.