The Food and Drug Administration has created a formal regulatory category for a device most parents have never heard of: a system that sits with a newborn incubator and cancels out the noise reaching the baby inside.
The agency published a final order in the Federal Register classifying the active noise attenuation system for infant incubators into Class II with special controls. The order took effect on publication and adds a new section, 21 CFR 880.5405, to the code governing general hospital devices.
