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U.S. Department of Health and Human Services

For Industry

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I want to manufacture an FDA-regulated product, where do I start?

Start by visiting the FDA web pages dedicated to that commodity. You will find valuable guidance there. The guidance quotes the law and regulations applicable. You can look up the laws and the regulations. If you require assistance, please contact the most appropriate FDA Small Business Contact.

After learning the requirements from FDA at the federal government level, don't forget to also learn the requirements from state and local authorities disclaimer icon. Note that other federal government agencies may also have jurisdiction over your product.

 

 

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