FDA reclassifies apnoea monitors:
This article was originally published in Clinica
The US FDA has reclassified apnoea monitors, moving them from a generic category set aside for breathing frequency monitors to their own separate category. The products will still be considered class II or medium risk devices but be subject to a new guidance document for apnoea monitors that identifies minimum performance, testing and labelling recommendations for the device. All future 510(k) submissions for apnoea monitors will have to comply with the new guidance document once the reclassification goes into effect on October 15. The FDA had initially proposed limiting the guidance to infants and children, but the final guidance was revised to make it applicable to adults as well.
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