Among the major assumptions in TCM (Traditional Chinese Medicine) are that health is achieved by maintaining the body in a "balanced state" and that disease is due to an internal imbalance of yin and yang. This imbalance leads to blockage in the flow of qi (vital energy) along pathways known as meridians. It is believed that there are 12 main meridians and 8 secondary meridians and that there are more than 2,000 acupuncture points on the human body that connect with them.



Acupuncture describes a family of procedures involving stimulation of anatomical locations on the skin by a variety of techniques. There are a variety of approaches to diagnosis and treatment in American acupuncture that incorporate medical traditions from China, Japan, Korea, and other countries. The most studied mechanism of stimulation of acupuncture points employs penetration of the skin by thin, solid, metallic needles, which are manipulated manually or by electrical stimulation. The majority of comments in this report are based on data that came from such studies. Stimulation of these areas by pressure, heat, and lasers is used in acupuncture practice, but because of the paucity of studies, these techniques are more difficult to evaluate.

In the past two decades, acupuncture has grown in popularity in the United States. The report from a Consensus Development Conference on Acupuncture held at the National Institutes of Health (NIH). Relatively few complications from the use of acupuncture have been reported to the FDA in light of the millions of people treated each year and the number of acupuncture needles used. Still, complications have resulted from inadequate sterilization of needles and from improper delivery of treatments.

Acupuncture needles used for acupuncture no longer need "investigational use" labeling. FDA recently reclassified them for "general acupuncture use" by qualified practitioners.

Acupuncture needles, which are used as part of a centuries-old Chinese healing technique, are medical devices under FDA regulations. Last March, the agency reclassified the needles from class III, a category that requires clinical studies, to class II, which means they can 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.

The agency's decision to reclassify acupuncture needles was based on a review of available data on acupuncture and the needles used for this purpose. Before a firm can market acupuncture needles in the United States, it must obtain clearance from FDA through the premarket notification (510k) process. 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.