pharmaphorum October 4, 2022
In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) were considered. Part 2 of this series is devoted to clinical decision support (CDS) software.
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022.
The final guidance follows the draft CDS software guidance issued on the same date in 2019. Since then, developers have sought clarity regarding the regulatory status of CDS, which is described as a variety of tools including, but not limited to: computerized alerts...
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