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.
*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*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.