Learning Center · Resources
U.S. Legal & Legislative Sources
Where to go for the actual text behind U.S. pharmaceutical and medical device regulation — the statutes, the regulations, and the day-to-day rulemaking that amends them.
These sit below the agencies on the main Resources page in one sense and above them in another: FDA's authority comes from a statute, and its regulations are the specific rules FDA writes under that statute. For a plain-language walkthrough of how these pieces connect, see How the law actually fits together in the History of the FDA article.
United States Code
Federal Statute
The official, government-published codification of federal law. FDA's core authority lives in Title 21, the section built from the Food, Drug, and Cosmetic Act and its amendments.
Visit official siteElectronic Code of Federal Regulations (eCFR)
Federal Regulations
The continuously updated, current-as-of-today version of the CFR. This is where FDA's actual binding rules live — cGMP in 21 CFR Parts 210–211, device regulations in 21 CFR Part 820, and so on.
Visit official siteFederal Register
Daily Rulemaking
The daily journal of the U.S. government, where FDA publishes proposed rules, final rules, and notices before they're folded into the CFR. Offers a free "Get Email Updates" alert service by agency or topic.
Visit official siteU.S. Code — Cornell Law School
Searchable Reference
Cornell's Legal Information Institute mirrors the U.S. Code with a much friendlier search and cross-reference experience. Trusted and widely used, but not an official government source — verify anything binding against uscode.house.gov.
Visit official siteCFR — Cornell Law School
Searchable Reference
The same Cornell Legal Information Institute treatment applied to the Code of Federal Regulations — easy to browse and search, useful for research, but the eCFR remains the authoritative current text.
Visit official siteA note on hierarchy: in order of legal authority, it runs statute (U.S. Code) → regulation (CFR) → agency guidance. A regulation has to be authorized by, and stay consistent with, the statute that created it.
This page covers the federal layer only. For how state, county, and city rules stack on top of it — using California and San Diego as a working example — see our Regulatory Compliance Hierarchy case study (PDF).
Trying to trace a requirement back to its source?
If you need help connecting a compliance question back to the statute or regulation behind it, I can help.
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