FDA regulations
Regulations issued by the US Food and Drug Administration, codified mainly in Title 21 of the Code of Federal Regulations.
Overview
FDA regulations govern drugs, biologics, medical devices, food, cosmetics and tobacco, covering approval, manufacturing quality, labelling, clinical trials, adverse-event reporting and electronic records.
As regulation it is binding and specific, and it is the layer most directly mapped to controls. The authorities most closely connected to it are FDA.
Check the official sources below for legal scope, applicable dates and exceptions. This entry is an explanatory reference, not legal advice.
Why it matters
FDA compliance gates market access for health products in the US.
Who it affects
Drug, device, biologics and food manufacturers, and clinical research organisations.
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 regulations. Select one to open it.
What to do about it
- 1Confirm whether you are in scope: who it covers, which activities and where.
- 2Break it into testable requirements.
- 3Map each requirement to a control and an owner.
- 4Track amendments, implementing rules and guidance.
- 5Keep sealed evidence for every control run.
From requirement to evidence.
FDA requirements are mapped by product and lifecycle stage.
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