Is your product regulated by the FDA?

What products come to mind when think of the FDA?


Based on commercials we see on TV, we most likely think of prescription drugs (for example, Humira, Zoloft, Cymbalta, just to name a few). Defribillators recently made the news via the CBS Sunday Morning segment "When Medical Implants Fail". aired on April 1, 2012. 


These examples are just one part of the FDA's mission. In actuality, the FDA regulates a wide range of products, from hospital beds to pet food. 


How do you know if the products you manufacture, service or import for sale within the USA are regulated by the FDA? 


The FDA has created a simple two-page questionnaire with yes/no questions that will help you determine if your product is regulated, and the relevant office you should contact you should contact with questions. FDA Basics for Industry is only a navigation guide - it should not be used as the final decision-making tool on the regulatory status of a product. Click here for an online version of the questions.


Please contact your nearest FDA Public Affairs Specialist or Small Business Representative for assistance on determination of regulatory status of your product. A directory of FDA offices in the field is available online.