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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 335.500 Razor Blades, Manicuring Instruments - Not Considered Devices Under 201(h) March 1995

Final
Docket Number:
FDA-2013-S-0610
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Office of Regulatory Affairs

BACKGROUND:

A correspondent inquired whether the term "device" as used in section 201(h) of *the Federal, Food, Drug, and Cosmetic Act (the Act)* includes such items as razors and manicuring implements.

POLICY:

*Devices are subject to the Act only when recognized in the official NF or USP intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or intended to affect the structure or any function of the body of man or other animals. Razor blades and manicuring instruments as ordinarily represented are not devices within the meaning of the Act.*

*Material between asterisks is new or revised*

Issued: 4/21/76
Reissued: 10/1/80
Revised: 9/24/87


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All written comments should be identified with this document's docket number: FDA-2013-S-0610.

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