The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services in the USA.
The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.
FDA approved requests are for items that are new or substantially different and need to demonstrate “safety and efficacy”. FDA clearance requests are for medical devices that prove they are “substantially equivalent” to the predicate devices already on the market.
Implants are found in medical devices.