DENIAL OF REQUEST FOR CHANGE IN CLASSIFICATION OF BREATHING FREQUENCY MONITOR AND ELECTROENCEPHALOGRAPH

The Food and Drug Administration (FDA) is denying the petitions submitted by IM Systems to reclassify the SleepCheck, the ActiTrac, and PAM-RL devices from class II (special controls) to class I (general controls). The agency is denying the petitions because the petitioner failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. FDA (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11115.htm)