What is the U.S. Food and Drug Administration (FDA)?

U.S. Food and Drug Administration Definition

The U.S. Food and Drug Administration (FDA) establishes regulations to protect the public health. Specifically, the FDA inspects, tests, approves, and creates safety standards for foods, drugs, chemicals, cosmetics, household products, and medical devices. Under the FDA’s regulations, medical device and biotechnology companies must comply with 21 CFR Part 820, Part 11, and other quality system requirements (QSR) to be able to sell products in the United States.

Related Terms

  • ISO 13485 Compliance
  • The European Union Medical Device Regulation (EU MDR)
  • Medical Device Compliance
  • Quality Management System (QMS)
  • Quality System Regulation (QSR)
  • Current Good Manufacturing Practice (CGMP)