FDA Relaxes Enforcement Policy On Fetal, Maternal Monitoring Devices So They Can Be Used At Home
A new guidance doc from the US FDA says the agency won’t penalize manufacturers of non-invasive fetal and maternal monitoring devices if they make changes to their products so they can be used in a home setting during the COVID-19 pandemic.
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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.
Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.
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.