title: Medical devices; general and plastic surgery devices; classification of the absorbable lung biopsy plug. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the absorbable lung biopsy plug into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the absorbable lung biopsy plug's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D020341:Absorbable Implants / Q000145:classification*; D001706:Biopsy / Q000295:instrumentation; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D008168:Lung / Q000601:surgery; D013518:Surgery, Plastic / Q000295:instrumentation; D013525:Surgical Instruments / Q000145:classification*; D014481:United States