the prescribing practitioner with adequate directions for their safe and effective use. Because the safety and effectiveness of acupuncture devices have not yet been adequately demonstrated, and labeling therefore cannot be devised, which would provide adequate directions for safe and effective use, they may not be labeled in accordance with the requirements for prescription devices as stated in 21 CFR 1.106(d). Until evidence is obtained demonstrating that acupuncture is a safe and effective medical technique, acupuncture devices must be limited to investigational or research use.
Current Food and Drug Administration regulations do not contain specific provisions governing the shipment of investigational devices in interstate commerce for clinical research or experimental use. The Commissioner of Food and Drugs is aware of the need for such regulations to provide adequate guidance as to the labeling for experimental devices to be used on human beings. Therefore, the Commissioner intends to publish at a later date proposed regulations which would govern all investigational devices. In the interim, this notice will apply to all acupuncture devices.
In order to establish guidelines under which manufacturers, packers, and distributors can properly label acupuncture devices for investigational use, the Food and Drug Administration met on September 22, 1972, with individuals concerned with the use of acupuncture in the United States. These included representatives of the States of California and New York, the city of New York, the American Society of Anesthesiologists, the National Institutes of Health, the Federation of State Medical Boards, the American Medical Association, medical practitioners, and the Food and Drug Administration Medical Device Advisory Committee. It was the consensus of this group that acupuncture devices should be restricted to investigational use by licensed practitioners and that the labeling for these devices should include this restriction in addition to other information.
Accordingly, the Commissioner of Food and Drugs concludes that until substantial scientific evidence is obtained by valid research studies supporting the safety and therapeutic usefulness of acupuncture devices, the Food and Drug Administration will regard as misbranded any acupuncture device shipped in interstate commerce if the following information does not appear in the labeling:
(a) The name of the device.
(b) The name and place of business of the manufacturer, packer, or distributor.
(c) An accurate statement of the quantity of the contents.
(d) The composition of the device and whether it is sterile, nonsterile, reusable, or disposable.
(e) The dimension or other pertinent physical characteristics of the device.
(f) The following statement: "Caution: Experimental device limited to investigational use by or under the direct supervision of a licensed medical or dental practitioner. This device is to be used only with informed consent under conditions designed to protect the patient as a research subject, where the scientific protocol for investigation has been reviewed and approved by an appropriate institutional review committee, and where conditions for such use are in accordance with State law."
Instructions for the use of the device for the purpose for which it is being investigated and, to the extent such information is known, any human hazards, contra-indication, precautions, or side effects associated with its use, should be provided to researchers and investigators. The Food and Drug Administration, however, will regard as misbranded any acupuncture device shipped in interstate commerce if accompanied by claims of diagnostic or therapeutic effectiveness.
Pending promulgation of separate regulations for conducting clinical investigations of investigational devices, researchers and investigators shall assure adequate informed consent and institutional committee review for such investigations, utilizing as a guideline the standards established for investigational drugs in 21 CFR 130.37 and in Division 10, unit C of form FD-1571, in 21 CFR 130.3(a)(2).
Dated: February 21, 1973.
Deputy Commissioner of Food and Drugs.
[FR Doc. 73-4540 Filed 3-8-73; 8:45 am]
AND NOW, to wit, this 25th day of January, 1977, after due consideration of the briefs and arguments of counsel in the above matter, IT IS ORDERED that Summary Judgment be and is hereby entered in favor of Plaintiff and against Defendant on the claim for forfeiture of two acupuncture devices labeled "ACUFLEX DUAL MODEL CZ-110" and "PRO-MED 1100".
IT IS FURTHER ORDERED that the motion for Summary Judgment of claimants Professional Medical Distributors, Inc. and Dr. Constance Haber be and is hereby denied.
IT IS FURTHER ORDERED that the counterclaim by claimant Professional Medical Distributor, Inc. for a protective order to prevent seizure of the devices be and is hereby dismissed.
IT IS FURTHER ORDERED that the counterclaim by Dr. Haber for damages arising from the seizure of the devices be and is hereby dismissed.
IT IS ALSO FURTHER ORDERED that the motion by Carl A. Eck, Esq., to withdraw his appearance as counsel for claimants because of their failure to cooperate and failure to pay legal fees be and is hereby granted, effective as of the date of this order.
DANIEL J. SNYDER, JR. / UNITED STATES DISTRICT JUDGE