[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Notices]
[Pages 72085-72086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33282]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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