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Not FDA Regulated

FDA Inspections

Approval Process

21 CFR Part 11

FDA Legislation

What The Food and Drug Administration Regulates

The Food and Drug Administration (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:

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

Biologics

• Poduct and manufacturing establishment licensing
• Safety of the nation's blood supply
• Research to establish product standards and develop
  improved testing methods

Cosmetics

• Safety
• Labeling

Radiation-Emitting Electronic Products

• Radiation safety performance standards for microwave ovens, television receivers, diagnosticx-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

• Lvestock feeds
• Pet foods
• Veterinary drugs and devices