Acupuncture Needle Status Changed

FDA Talk Paper T96-21
April 1, 1996

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.

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.


FDA Talk Papers are prepared rgw the FDA Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more informaiton becomes available. Talk Papers are not intended fo general distribution, but all information in them is public, and full texts are available upon request.

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