FDA DENIES RECLASSIFICATION APPLICATION

The FDA said in the July 14 issue of the Federal Register that it 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 application is denied 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, according to the FDA.

There are three categories of devices: Class I (general controls), Class II (special controls) and Class III (premarket approval).

In 1979 the FDA classified the electroencephalograph into Class II, and in 1982 the FDA classified the breathing frequency monitor into Class II. On Aug. 18, 2004, IM Systems submitted three petitions requesting FDA to reclassify the devices to Class I.

But after reviewing the applications, the FDA said it found that the petitions do not contain any valid scientific evidence to support a conclusion that general controls would provide reasonable assurance of the devices' safety and effectiveness for their intended uses or that special controls are not necessary to provide reasonable assurance of the safety and effectiveness of the devices.

To view the Federal Register notice, go to: www.fda.gov/OHRMS/DOCKETS/98fr/E6-11115.htm (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11115.htm).