The FDA regulates approval, labeling, manufacturing, and postmarket surveillance for drugs and medical devices, and regulates food, cosmetics, and tobacco products. Approval pathways differ by product category and risk classification.
Adverse event reporting is required for approved products.
Alternative Names:
Food and Drug Administration
Why it Matters?
The approval pathway determines preemption exposure, since premarket approved devices receive broad protection while cleared devices generally do not, and generic drugs occupy a different position from brand. Adverse event databases are also a standard discovery target, because reports predating the plaintiff's injury establish notice. Warning letters and inspection findings serve the same function.
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Frequently asked questions
Why does the approval pathway matter?
What FDA records are discovery targets?
