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FDA Relaxes Enforcement Policy On Fetal, Maternal Monitoring Devices So They Can Be Used At Home

 
• By Shawn M. Schmitt

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.

Professional doctor screening of pregnant woman by ultrasound. Fetal health monitoring. Diagnostic, healthcare, medical service

The US Food and Drug Administration 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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