[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Rules and Regulations]
[Pages 64616-64617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31047]
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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.
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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