FDA - US Food and Drug Administration

The FDA or the Food and Drug Administration is the agency of the USA that regulates and supervises food, tobacco, drugs, cosmetics, medical devices, vaccines, biopharmaceuticals, radiation emiting devices and veterinary products. It also deals with promoting and protecting public health by encouraging innovations and providing the public accurate information on improving their health.

The Commissioner of Food and Drugs is in charge of the FDA, a person that is appointed by the President, advised by the Senate and reporting to the Secretary of Health and Human Services. The agency is run by the United States Department of Health and Human Services, a federal executive department of the United States

The Center for Devices and Radiological Health or CDRH is the department that deals with premarket approval for medical devices, as well as supervises the safety, manufacturing and performance of the devices.

The structure of the Center for Devices and Radiological Health:

  • Office of the Center Director
  • Office of Communication, Education, and Radiation Programs
  • Office of Compliance
  • Office of Device Evaluation
  • Office of In Vitro Diagnostic Device Evaluation and Safety
  • Office of Management Operations
  • Office of Science and Engineering Laboratories
  • Office of Surveillance and Biometrics
  • Major Regulations

Major Regulations

Some of the most important regulations for medical devices in the USA are:

A full list of FDA regulations can be found here.

Contact details:

Links to Medical Device Associations in the USA: