Zdrowie i gospodarka · 13/12/2002

Medical Devices; Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA." Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the arrhythmia detector and alarm from class III (premarket approval) to class II (special controls). If the device is reclassified, FDA intends that this guidance document will serve as the special control. This guidance is neither final nor is it in effect at this time.