The U.S. Food and Drug Administration (FDA), as we know it today, came into existence in 1930. It is the pharmaceutical and medical device regulatory body for the United States.

FDA Rules and Regulations (Summary of the FDA’s process for rulemaking)

The FDA uses the Code of Federal Regulations (CFR) to regulate food, drugs and medical devices. The CFR is the codification of the general and permanent rules published in the Federal Register. These rules are known as ‘administrative law’.

Standard-setting activities include:

• material specifications
• testing methods
• manufacturing practices
• product standards
• scientific protocols
• the development of performance characteristics
• compliance criteria
• labeling
• other technical or policy criteria.

FDA Recognized Consensus Standards Database

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