Acupuncture Needles: Rules and Regulations
Food and Drug Administration, HHS

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Federal Register: December 6, 1996 (Volume 61, Number 236)]
[Rules and Regulations]
[Page 64616-64617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket Number 94P-0443]

Medical Devices; Reclassification of Acupuncture Needles for the Practice of Acupuncture

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is announcing that it is reclassifying acupuncture needles for the practice of acupuncture and substantially equivalent devices of this generic type from class III (premarket approval) into class II (special controls). FDA is also announcing it has issued an order in the form of a letter to the Acupuncture Coalition reclassifiying acupuncture needles. This action is in response to petitions filed by the Acupuncture Coalition and in keeping with, but not dependent upon, the recommendation of FDA's Anesthesiology Devices Advisory Panel (the Panel). This action is being taken because the agency believes that there is sufficient information to establish that special controls will provide reasonable assurance of the safety and effectiveness of acupuncture needles.

EFFECTIVE DATE: December 6, 1996.

FOR FURTHER INFORMATION CONTACT: Timothy A. Ulatowski, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443- 8879.

SUPPLEMENTARY INFORMATION: On December 6, 1995, FDA filed reclassification petitions from the Acupuncture Coalition, which includes representatives of the following manufacturers: Carbo (Mfg.), China; Hwa-To, China; Chung Wha, South Korea; Taki, South Korea; Dong Bang, South Korea; Tseng Shyh Co., Taiwan; HCD, France; Sedatelec, France; Seirin-Kasei (Mfg.), Japan; Ito Co., Japan; and Ido-No-Nippon- Sha, Japan, requesting reclassification of acupuncture needles from class III to class II. On March 29, 1996, FDA issued an order (Ref. 1) in the form of a letter, to the petitioners reclassifying acupuncture needles for the practice of acupuncture and substantially equivalent devices of this generic type from class III to class II. Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) ( 21 U.S.C. 360c(f)(2)) and Sec. 860.134 ( 21 CFR 860.134) provide for the reclassification by order of devices not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments.

Under section 513(f)(2) of the act and Sec. 860.134, FDA may refer a reclassification petition to an appropriate panel. Although FDA did not refer the reclassification petitions submitted by the Acupuncture Coalition to a panel, the Anesthesiology Devices Advisory Panel (the Panel) had previously considered the classification of acupuncture needles and other acupuncture devices and recommended that acupuncture needles be placed into class II, as reported in the Federal Register of November 2, 1979 (44 FR 63292 at 63299) (Ref. 2). The supplemental data sheet completed by the Panel on November 30, 1976 (Ref. 3), listed sepsis, excessive trauma, and perforation of blood vessels and organs as specific risks, and recommended restricting the device to prescription use. FDA's decision to reclassify acupuncture needles as class II is in keeping with, but not dependent upon, the recommendation of the Panel.

FDA determined that acupuncture needles could safely be reclassified from class III to class II with the implementation of special controls. Acupuncture needles are devices intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle and may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.

The order identified the special controls needed to provide reasonable assurance of the safety and effectiveness of acupuncture needles. Those special controls are in compliance with: (1) Labeling provisions for single use only and the prescription statement in Sec. 801.109 ( 21 CFR 801.109) (restriction to use by or on the order of qualified practitioners as determined by the States), (2) device material biocompatibility, and (3) device sterility. FDA believes that information for use, including: Indications, effects, routes, methods, and frequency and duration of administration; and any hazards, contraindications, side effects, and precautions are commonly known to qualified practitioners of acupuncture. Therefore, under Sec. 801.109(c), such indications do not need to be on the dispensing packaging, but sale must be clearly restricted to qualified practitioners of acupuncture as determined by the States. Guidance on the type of information needed to support biocompatibility and sterility of

[[Page 64617]]

acupuncture needles is available in the General Hospital Branch guidance document entitled ``Guidance on the Content of Premarket Notification (510(k)) Submissions for Hypodermic Single Lumen Needles'' (draft), April 1993 (Ref. 4). A copy of this guidance document is available from the Division of Small Manufacturers Assistance (HFZ- 220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850-4307, 301-443- 6597 or 800-638-2041 and FAX 301-443-8818.

Consistent with the act and the regulations, after thorough review of the clinical data submitted in the petitions, and after FDA's own literature search, on March 29, 1996, FDA sent the Acupuncture Coalition a letter (order) reclassifying acupuncture needles for general acupuncture use, and substantially equivalent devices of this generic type, from class III to class II (special controls). As required by Sec. 860.134(b)(7), FDA is announcing the reclassification of the generic type of device. Additionally, FDA is amending part 880 ( 21 CFR part 880 ) to include the classification of acupuncture needles for the practice of acupuncture by adding new Sec. 880 .5580.

Environmental Impact

The agency has determined that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Under 21 CFR 25.24(e)(2), the reclassification of a device is categorically exempt from environmental assessment and environmental impact statement requirements. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Analysis of Impacts

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because reclassification of devices from class III to class II will relieve some manufacturers of the cost of complying with the premarket approval requirements of section 515 of the act ( 21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.

Paperwork Reduction Act of 1995

FDA concludes that the labeling requirements in this final rule are not subject to review by the Office of Management and Budget because they do not constitute a ``collection of information'' under the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Rather, the proposed warning statements are ``public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)).

References

The following references have been placed on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. FDA letter (order) to the Acupuncture Coalition dated March 29, 1996.
2. Classification of anesthesiology devices, development of general provisions; 44 FR 63292 at 63299, November 2, 1979.
3. Anesthesiology Devices Advisory Panel's supplemental data sheet, November 30, 1976.
4. Guidance on the Content of Premarket (510(k)) Submissions for Hypodermic Single Lumen Needles (draft), April 1993.

List of Subjects in 21 CFR Part 880

Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:

PART 880 --GENERAL HOSPITAL AND PERSONAL USE DEVICES

1. The authority citation for 21 CFR part 880 continues to read as follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351, 360, 360c, 360e, 360j, 371).

2. New Sec. 880 .5580 is added to subpart F to read as follows:

Sec. 880 .5580 Acupuncture needle.

(a) Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
(b) Classification. Class II (special controls). Acupuncture needles must comply with the following special controls:
(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, (2) Device material biocompatibility, and
(3) Device sterility.

Dated: November 20, 1996.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 96-31047 Filed 12-5-96; 8:45 am]
BILLING CODE 4160-01-F


Information resource: http://acupuncture.com/News/Need6.htm