FDA Compliance, FDA Regulations and FDA Inspections

Overview of FDA Compliance, FDA Regulations, FDA Inspections, FDA Approval Process, 21 CFR Part 11 and FDA Legislation

Home Page • Not Regulated By FDA
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

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What The Food and Drug Administration Doesn’t Regulate

Home Page • Not Regulated By The FDA • FDA Inspections
FDA Approval Process • 21 CFR Part 11 • FDA Legislation

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