How do I know if my product is regulated by FDA?

Download the FDA Basics for Industry: Navigation Guide (PDF – 40KB)

The general navigation guide below is provided in order to be helpful to companies wondering if their planned activities would be subject to regulation by FDA. FDA regulates a range of products.

The information below is a simplified flow chart intended to provide companies a start in contacting a relevant FDA office with questions. It should not be used to make a final decision about the regulatory status of a product. You should refer to the Federal Food, Drug, and Cosmetic Act and other laws FDA enforces as well as Title 21 of the Code of Federal Regulations, which is reserved for FDA rules.

Please find more information and resources on this topic here:

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