Food and Drug Administration (FDA)
The US federal agency regulating drugs, biologics, medical devices, food, cosmetics and tobacco.
Overview
Part of the Department of Health and Human Services, the FDA approves and clears products, inspects manufacturing facilities, oversees clinical trials, monitors safety after approval and takes enforcement action, from warning letters to seizures.
Its powers include writing binding rules, supervising and examining the organisations it oversees, granting and withdrawing licences or registrations and investigating and imposing penalties.
In the United States it works at federal level. Instruments connected to it in this glossary include FDA regulations.
Check the official sources below for legal scope, applicable dates and exceptions. This entry is an explanatory reference, not legal advice.
Why it matters
It can both set the rules and punish breaches of them, so its priorities shape compliance risk directly.
Who it affects
Organisations in healthcare, pharmaceuticals and medical devices in the United States.
Where it sits
Ten linked steps connect where you operate to the proof that you complied.
- 01Jurisdiction
- 02Industry
- 03Activity
- 04Authority
- 05Regulation
- 06Requirement
- 07Guidance
- 08Control
- 09Evidence
- 10Enforcement
Connections
The terms most closely tied to FDA. Select one to open it.
What to do about it
- 1Confirm whether FDA has power over you, and through which licence, registration, membership or activity.
- 2Follow its rules, guidance and enforcement publications as they are issued.
- 3Map each obligation it creates to a control with a named owner.
- 4Keep examination-ready evidence for its highest-risk obligations.
From requirement to evidence.
Regulation Layer tracks its publications in the change feed, maps its obligations to your controls, and links its enforcement actions to the obligations they cite.
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