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Acupuncture Needle Status Changed
We have received numerous inquiries
about the status of acupuncture needles, which have been under review by the
agency.
FDA has announced that acupuncture needles have been reclasssified from
Class III to Class II for "general
acupuncture use" by licensed, registered or certified practitioners. As part
of this reclassification, FDA has
determined that the current "investigational use" labeling requirements no
longer apply to acupuncture needles intended for general use by qualified
practitioners.
The following can be used to answer
questions:
In response to petitions submitted by the acupuncture community, FDA has
reclassified acupuncture needles for general use from Class III, a category
in which clinical studies are required to establish safety and
effectiveness, to Class II, a category which involves less stringent
controls by FDA but requires good manufacturing and proper labeling.
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.
-More- Page 2, T96-21, Acupuncture
Needle
Firms that wish to market acupuncture
needles for general use in the United States will be required to obtain
pre-market clearance from FDA through the pre-market notification (510k)
process. Manufacturers will be required to label the needles for single use
only. Acupuncture needles must also bear a prescription labeling statement
which restricts their use to qualified practitioners as determined by the
states. Manufacturers will also have to provide information about
device material bio-compatibility and sterility.Foreign manufacturers will
have to meet the same pre-market clearance and manufacturing quality
requirements as U.S. manufacturers.
Information source:
http://www.fda.gov/bbs/topics/ANSWERS/ANS00722.html
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