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COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification

The US agency has added gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the coronavirus pandemic – will not require a new premarket notification to be marketed for remote monitoring.

Guidance word in red keyboard buttons

The US Food and Drug Administration on 28 October updated a guidance document it released earlier this year to allow certain remote monitoring devices on the market without the need for a premarket notification. It includes more standards and devices that the agency says is meant to minimize patient-physician interaction during the coronavirus pandemic.

The FDA in March published the emergency guidance, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring...

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