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FDA Policy on Remote Auditing Pilot Program FDA

Monitoring Devices: A New FDA Policy

The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance dedicated to enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019...

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FDA Policy on Diagnostics Testing for COVID-19

The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued guidance for clinical laboratories dedicated to Coronavirus Disease-2019 during the public health emergency. The document covers the aspects related to molecular...

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