What FDA Regulates

March 24, 2012

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency’s specific responsibilities include:

Biologics

  • product and manufacturing establishment licensing
  • safety of the nation’s blood supply
  • research to establish product standards and develop improved testing methods

Cosmetics

  • safety
  • labeling

Drugs

  • product approvals
  • OTC and prescription drug labeling
  • drug manufacturing standards

Foods

  • labeling
  • safety of all food products (except meat and poultry)
  • bottled water

Medical Devices

  • premarket approval of new devices
  • manufacturing and performance standards
  • tracking reports of device malfunctioning and serious adverse reactions

Radiation-Emitting Electronic Products

  • radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
  • accrediting and inspecting mammography facilities

Veterinary Products

  • livestock feeds
  • pet foods
  • veterinary drugs and devices

Source: FDA


Biological Products

June 27, 2008

Background

Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies.

Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.

What biological products does FDA regulate?

The Center for Biologics Evaluation and Research (CBER) within FDA regulates a wide range of biological products, including

  • allergenic extracts (e.g. for allergy shots and tests)
  • blood and blood components
  • gene therapy products
  • devices and test kits
  • human tissue and cellular products used in transplantation
  • vaccines