This action is being taken because the agency believes that there is sufficient information to establish that special controls will provide reasonable assurance of the safety and effectiveness of acupuncture needles. December 6, 1996. 860.134, FDA may refer a reclassification petition to an appropriate panel. FDA's decision to reclassify acupuncture needles as class II is in keeping with, but not dependent upon, the recommendation of the Panel. FDA determined that acupuncture needles could safely be reclassified from class III to class II with the implementation of special controls.
Acupuncture needles are devices intended to pierce the skin in the practice of acupuncture.
The device consists of a solid, stainless steel needle and may have a handle attached to the needle to facilitate the delivery of acupuncture treatment. The order identified the special controls needed to provide reasonable assurance of the safety and effectiveness of acupuncture needles. As required by Sec. The agency has determined that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.