The Food and Drug administration (FDA) is a federal agency that is part of Department of Health and Human Services. The Department of Health and Human Services is overseen at the cabinet level by the Secretary of Health and Human Services. The Department of Health and Human Services was originally founded in 1862 as a laboratory that analyzed food, fertilizers, and agricultural substances. Since then, the Food and Drug Administration has grown to regulate over 1 trillion dollars worth of consumer goods.

The FDA is responsible for protecting the public health. The scope of the FDA’s regulatory authority is broad. Their responsibilities are closely related to those of several other government agencies. Traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction are things like foods, drugs, medical devices, biologics, radiation emitting products, cosmetics, veterinary drugs, and tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The FDA has a comprehensive website, where they post all public information.

> #### U S Food and Drug Administration Home Page

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.