FDA Classification of Acupuncture Needles 1996

Acupuncture needles are medical devices under federal Food and Drug Administration regulations. In 1996, the FDA reclassified the needles from class III to class II, meaning the needles could be used by licensed, registered or certified acupuncture practitioners. As with other class II devices, the needles are required to have proper labeling, and good manufacturing practices must be followed.  Manufacturers must include on the label the statement "for single use only" and provide information about device material sterility and compatibility with the body. The needles must also bear a prescription label restricting use to qualified practitioners as determined by individual states. Foreign manufacturers must meet the same premarket clearance and manufacturing quality requirements as U.S. manufacturers.