Latest Federal Register Notices

DEVICES

Comments Extended on Electrical Stimulation Devices
Federal Register Proposed rule: FDA is extending the comment period for a 4/25 proposed rule in which the agency requested comments for a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior. Comments should be submitted by 7/25. To view this notice, click here.

FDA Reclassifies Cardiac Compressors into Class 2
Federal Register Final order: FDA is reclassifying external cardiac compressors (under FDA product code DRM), a preamendments Class 3 device, into Class 2 (special controls). The agency is also creating a separate classification regulation for a subgroup of devices previously included within this classification regulation, to be called cardiopulmonary resuscitation (CPR) aids, and reclassifying these devices from Class 3 to Class 2 for CPR aids with feedback and to Class I for CPR aids without feedback. To view this final order, click here.