FDA - US Food and Drug Administration

The Food and Drug Administration (FDA) is the agency of the United States that regulates and supervises food, tobacco, drugs, cosmetics, medical devices, vaccines, biopharmaceuticals, radiation emitting devices, and veterinary products. It also deals with promoting and protecting public health by encouraging innovation and providing accurate information to the public about improving their health.

The FDA is run by the Commissioner of Food and Drugs, a person 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 (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

A list of FDA regulations can be found here on our website.

Contact details:

• Website: https://www.fda.gov/

Links to Medical Device Associations in the USA:

• Advanced Medical Technology Association (AdvaMed)
• American Association for Clinical Chemistry (AACC)
• American Institute of Ultrasound in Medicine (AIUM)
• American Society for Quality (ASQ)
• Analytical & Life Science Systems Association (ALSSA)
• Association for the Advancement of Medical Instrumentation (AAMI)
• Association of Clinical Research Professionals (ACRP)
• Association of Medical Device Reprocessors (AMDR)
• Association of Medical Diagnostics Manufacturers (AMDM)
• BIOCOM
• BioForward
• Clinical and Laboratory Standards Institute (CLSI)
• Diagnostic Marketing Association (DxMA)
• Emergency Care Research Institute (ECRI)
• Indiana Medical Devices Manufacturers Council, Inc. (IMDMC)
• Medical Alley Association
• Medical Device Innovation, Safety and Security Consortium (MDISS)
• Medical Device Manufacturers Association (MDMA)
• MichBio
• Regulatory Affairs Professionals Society (RAPS)