[Federal Register: December 23, 1999 (Volume 64, Number 246)]
[Notices]
[Page 72085-72086]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de99-66]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-5002]


Acupuncture Devices and Accessories; Revocation of Compliance
Policy Guide 7124.11

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking the
Compliance Policy Guide (CPG) entitled ``Sec. 305.100 Acupuncture
Devices and Accessories (CPG 7124.11)'' to eliminate obsolete
compliance policy. In general, this CPG no longer reflects current
agency policy because acupuncture needles have been reclassified from
class III to class II (special controls).

DATES: Effective January 24, 2000.

ADDRESSES: Submit written requests for single copies of the CPG to the
Division of Compliance Policy (HFC-230), Office of Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0411 or FAX your request to 301-827-0482.
A copy of the CPG may be seen in the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852 between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0411.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued the CPG entitled ``Sec. 305.100 Acupuncture Devices and
Accessories (CPG 7124.11)'' on June 15, 1976. This CPG considered
acupuncture devices and accessories as investigational devices subject
to the investigational device exemptions (IDE) regulations (21 CFR part
812). As such, these class III devices were permitted to be distributed
only for the purpose of conducting clinical studies to establish their
safety and effectiveness. In the absence of an approved premarket
approval application, the sale, promotion, and commercial distribution
of these acupuncture devices and accessories were prohibited.
    In response to a reclassification petition that was submitted to
FDA by the Acupuncture Coalition, the agency reclassified acupuncture
needles from class III to class II (special controls) in the Federal
Register of December 6, 1996 (61 FR 64616). The classification
regulation (21 CFR 880.5580) for solid, stainless steel, acupuncture
needles requires that these class II devices must comply with special
controls for single use labeling, prescription labeling,
biocompatibility, and sterility.
    Currently, an acupuncture needle that is intended to pierce the
skin in the practice of acupuncture may be

[[Page 72086]]

commercially distributed if it is the subject of a cleared premarket
notification (510(k)), complies with the special controls, and meets
all other applicable statutory and regulatory requirements.
    Given the reclassification of acupuncture needles, FDA is revoking
CPG 7124.11, in its entirety, to eliminate obsolete compliance policy.

II. Electronic Access

    Prior to January 24, 2000, a copy of the CPG may also be downloaded
to a personal computer with access to the Internet. The Office of
Regulatory Affairs (ORA) Home Page includes the referenced document
that may be accessed at http://www.fda.gov/ora/compliance__ref/cpg/
cpgdev/cpg305-100.html.

    Dated: December 7, 1999.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 99-33282 Filed 12-22-99; 8:45 am]
BILLING CODE 4160-01-F