[Federal Register Volume 67, Number 172 (Thursday, September 5, 2002)]
[Notices]
[Page 56850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 90D-0427]


Class III Medical Devices Without Premarket Clearance; Revocation 
of Compliance Policy Guide 7124.30

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of a Compliance Policy Guide (CPG) entitled ``Sec. 300.700 
Direct Reference Authority for Class III Medical Devices Without a 
Premarket Notification (510(k)) or an Approved Premarket Approval 
Application (PMA) (CPG 7124.30).'' This CPG no longer reflects current 
agency policy.

DATES: The revocation is effective October 7, 2002.

ADDRESSES: Submit written requests for single copies of the CPG 7124.30 
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, FAX 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, between 9 
a.m. and 4 p.m., Monday through Friday. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the CPG.

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

    Section 513(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360c(a)(1)(C)) describes a class III device, in 
part, as represented for use in supporting or sustaining human life, in 
preventing impairment of human health or presenting an unreasonable 
risk of illness or injury. An individual or firm that commercially 
distributes a class III device, in interstate commerce, without an 
approved premarket approval application (PMA) or a substantially 
equivalent premarket notification (510(k)) is in violation of the act. 
In legal terms, the device is adulterated in accordance with section 
501(f)(1) of the act (21 U.S.C. 351(f)(1)) and misbranded within the 
meaning of section 502(o) of the act (21 U.S.C. 352(o)).
    On February 26, 1991, FDA issued the CPG entitled ``Sec. 300.700 
Direct Reference Authority for Class III Medical Devices Without a 
Premarket Notification (510(k)) or an Approved Premarket Approval 
Application (PMA) (CPG 7124.30).'' This CPG authorizes FDA's field 
districts to issue a Warning Letter or recommend a seizure action, if 
warranted, without prior concurrence and review by FDA's Center for 
Devices and Radiological Health (CDRH) for the referenced violations. 
This procedure no longer reflects current agency policy. Field 
districts should forward all Warning Letter and seizure recommendations 
concerning device premarket clearance violations to CDRH for 
concurrence. The Regulatory Procedures Manual includes the latter 
procedure.
    FDA is revoking CPG 7124.30, in its entirety, to eliminate obsolete 
compliance policy.

II. Electronic Access

    Prior to the revocation effective date (see DATES), a copy of the 
CPG may also be downloaded to a personal computer with access to the 
Internet. The Office of Regulatory Affairs home page includes the CPG 
that may be accessed at http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg300-700.html.

    Dated: August 28, 2002.
John Marzilli,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 02-22638 Filed 9-4-02; 8:45 am]
BILLING CODE 4160-01-S