FDA Loosens Controls on Absorbable Lung Biopsy Plug Devices

The Food and Drug Administration reclassifying absorbable lung biopsy plugs as Class II devices that do not require premarket approval,in a final rule that takes effect April 9. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. The devices will be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling,