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These FDA web pages address the labeling requirements for foods under the Federal Food, Drug, and Cosmetic Act and its amendments.
Device Advice - Introduction to labeling requirements for medical devices, including advertising, over the counter, exemptions, in vitro diagnostics, investigational devices, quality system ...
The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. Later sections in this chapter discuss ...
This guidance is a summary of the required statements for food labels under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.
Human prescription drug labeling (1) contains a summary of the essential scientific information needed for the safe and effective use of the drug; and (2) includes the Prescribing Information, FDA ...
Device Advice - Regulations and requirements for labels and other written, printed or graphic materials (labeling) that accompanies or is associated with a medical device.
For more information on labeling, including Physician Labeling Rule (PLR) requirements, guidances, presentations, sample templates and format tools, and established pharmacologic class (EPC ...
Away-From-Home Foods Including Menu and Vending Machine Labeling. Menu and Vending Machine Labeling Requirements Main Page. Temporary Policy Regarding Certain Food Labeling Requirements During the ...
Regulations [21 CFR 701.2] published by the FDA offer detailed information on how to comply with the requirement for prominent and conspicuous placement of information on cosmetic labels or labeling.
Subpart G - Specific Labeling Requirements for Specific Drug Products § 201.300 - Notice to manufacturers, packers, and distributors of glandular preparations. § 201.301 - Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.