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COVID-19 Shows Remote Monitoring Can Work For Pre-Cert Program

In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.

Businessman on blurred background holding and touching floating stethoscope 3D rendering - Image

The COVID-19 pandemic has provided US regulators with a unique opportunity to test whether they can successfully use remote monitoring to evaluate the performance of firms making software as a medical device (SaMD). So far, it seems it is a viable option, a new report says.

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) published a report on 14 September updating stakeholders of the progress it’s made with its Precertification (Pre-Cert) Program, and what its next steps are

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