FDA

Food and Drug Administration

Ensures safety of food, drugs, medical devices, and cosmetics

Key Regulations

21 CFR 117active

Current Good Manufacturing Practice and Hazard Analysis for Human Food

Requires food facilities to implement preventive controls for food safety including hazard analysis.

21 CFR 314active

Applications for FDA Approval to Market a New Drug

Establishes the process for gaining FDA approval to sell new drugs, requiring proof of safety and effectiveness.

21 CFR 860active

Medical Device Classification Procedures

Classifies medical devices into three risk categories with increasing regulatory requirements for each class.

21 CFR 101active

Food Labeling Requirements

Requires packaged foods to display a standardized Nutrition Facts label and ingredient list.

21 CFR 1140active

Tobacco Product Restrictions for Minors

Restricts the sale of tobacco products to minors and limits marketing practices.

21 CFR 312active

Investigational New Drug Application

Requires FDA approval before new drugs can be tested on humans in clinical trials.

21 CFR 111active

Current Good Manufacturing Practice for Dietary Supplements

Establishes manufacturing quality standards for dietary supplement producers to ensure product safety.

Enforcement Actions

No enforcement actions found for FDA in the current dataset.