ANSWERS
04/01/1996

<TITLE> ACUPUNCTURE NEEDLE STATUS CHANGED </TITLE>
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T96-21                                             Sharon Snider
April 1, 1996                                      (301) 443-3285

                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.
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