Does FDA Approve Acupuncture?

Does FDA Approve Acupuncture?
By Jerry Hall

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 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 that incorporate medical
traditions from China, Japan, Korea, and other countries. The
most studied mechanism of stimulation of 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 practice,
but because of the paucity of studies, these techniques are more
difficult to evaluate.

In the past two decades, has grown in popularity in
the United States. The report from a Consensus Development
Conference on 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 no longer need
"investigational use" labeling. FDA recently reclassified them
for "general 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 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 needles was
based on a review of available data on 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.

About the Author: originated in China more than
2,000 years ago, making it one of the oldest and most commonly
used medical procedures in the world. Does it Really Work? Find
out at http://AcupuncturePoint.smartreviewguide.com

Source: http://www.isnare.com

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