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Color Certification | FDA Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or ...

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Medical Device Exemptions 510(k) and GMP Requirements Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these ...

Color Additives History | FDA Julie N. Barrows, Ph.D., is a consumer safety officer in the Office of Cosmetics and Colors, FDA CFSAN. She has worked at FDA since 1988, first in research on color additive certification and ...

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Product Classification - Food and Drug Administration No Summary Malfunction Reporting: Eligible Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and

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