Medical Devices; Reclassification of Acupuncture Needles for the Practice of Acupuncture

Streszczenie

The Food and Drug Administration (FDA) is announcing that it is reclassifying acupuncture needles for the practice of acupuncture and substantially equivalent devices of this generic type from class III (premarket approval) into class II (special controls). FDA is also announcing it has issued an order in the form of a letter to the Acupuncture Coalition reclassifiying acupuncture needles. This action is in response to petitions filed by the Acupuncture Coalition and in keeping with, but not dependent upon, the recommendation of FDA's Anesthesiology Devices Advisory Panel (the Panel). 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.