FDA Relaxes Requirements for Tuberculosis Detection Devices

The Food and Drug Administration is formally reclassifying some devices used for detection of tuberculosis as Class II devices that do not require premarket approval, in a final order that takes effect June 30. "Nucleic acid-based systems for mycobacterium tuberculosis complex in respiratory specimens" had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing and labeling, and will not be exempt from premarket notification requirements.