FDA reclassifies sharps needle destruction device

The FDA has reclassified the needle destruction device, now renamed “sharps needle destruction device,” from class III (requiring premarket approval) to class II (requiring special controls) to indicate the level of regulatory controls needed to provide reasonable assurance of the safety and effectiveness of the device. The required special controls relate to performance testing, cleaning and disinfection instructions, electromagnetic compatibility and electrical safety, software verification, and labeling. Read the FDA notice.