Zdrowie i gospodarka · 22/09/2000

Medical Devices; Apnea Monitor; Special Controls

The Food and Drug Administration (FDA) is publishing a proposed rule to create a separate classification for the apnea monitor. The device currently is included in the generic type of device called breathing frequency monitors. The apnea monitor will remain in class II, but will be subject to a special control. The special control is an FDA guidance document that identifies minimum performance, testing, and labeling recommendations for the device. Elsewhere in this issue of the Federal Register, FDA is withdrawing a proposed mandatory standard for infant apnea monitors and is announcing the availability of a draft guidance document that will serve as the special control. FDA is taking these actions because it believes that they are necessary to provide reasonable assurance of the safety and effectiveness of the apnea monitor.