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U.S. Department of Health and Human Services

For Industry

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FDA Basics for Industry

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

It depends on what the product is and how it is marketed. For more information, see FDA's general navigation guide for manufacturers of FDA-regulated products and start-ups.

 

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sunscreen, pills, cigarettes, medical imaging device
 

What should I expect during an inspection?

FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem.

 

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Inspectors at the grocery store
 

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...

 

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man in suit holding a pen
 
 
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FDA Basics for Industry Topics A - Z Index

Commissioner Hamburg Speaks About FDA Basics for Industry

FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry in a user-friendly format.

 
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