FDA Issues Proposed Rule on Classifying Bacillus IVD Test Kits

The FDA is re-proposing classifying in vitro diagnostic devices for Bacillus species detection into Class 2 with special controls, a move the agency says would help assure the safety and effectiveness of the devices.

The agency originally proposed to classify these devices into Class 2 in May 2011, but withdrew the draft guidance this May — along with other guidances it had not been finalized — as part of a transparency initiative.

The FDA also has released final orders classifying ultraviolet radiation chamber disinfection devices and reclassifying electrical salivary stimulator systems.

UV radiation chamber disinfection devices are now in Class 2 with special controls. The salivary stimulator system, a postamendments Class 3 device, is now reclassified into Class 2 with special controls.

In addition, the FDA issued a final order exempting electric positioning chairs, Class 2 devices, from premarket notification requirements. To be 510(k)-exempt, the devices must meet certain conditions, such as testing that shows the safety controls are adequate to prevent user falls if the devices fail, the ability to withstand the rated user weight load, and the longevity of the devices to withstand external forces.

The Federal Register notice on the proposed rule on Bacillus species is here: http://www.fdanews.com/11-15-FDA-Rule.pdf. The notices on the final orders on classifying UV radiation chamber disinfection devices and on reclassifying electrical salivary stimulator systems are here, respectively: http://www.fdanews.com/11-15-FDA-Order1.pdf and http://www.fdanews.com/11-15-FDA-Order2.pdf. The notice on the final order on electric positioning chairs is here: http://www.fdanews.com/11-15-FDA-Order3.pdf. — Jonathon Shacat