December 6, 1996 (Volume 61, Number 236)]
[Rules and Regulations]
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
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
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
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
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.
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
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
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
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
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
(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