Chapter I – Food and Drug Administration

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Chapter I – Food and Drug Administration is the portion of Title 21 of the Code of Federal Regulations that contains the primary federal rules governing the oversight of food, drugs, medical devices, and related products by the U.S. Food and Drug Administration.

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Statements (42)

Predicate Object
instanceOf federal regulation
portion of Title 21 of the Code of Federal Regulations
administeredBy U.S. Food and Drug Administration NERFINISHED
appliesTo biological products regulated by the U.S. Food and Drug Administration
cosmetics regulated by the U.S. Food and Drug Administration
food products regulated by the U.S. Food and Drug Administration
human drugs regulated by the U.S. Food and Drug Administration
medical devices regulated by the U.S. Food and Drug Administration
radiation-emitting electronic products regulated by the U.S. Food and Drug Administration
tobacco products regulated by the U.S. Food and Drug Administration
veterinary products regulated by the U.S. Food and Drug Administration
codifiedIn Code of Federal Regulations NERFINISHED
country United States of America
surface form: United States
governs oversight of drugs by the U.S. Food and Drug Administration
oversight of food by the U.S. Food and Drug Administration
oversight of medical devices by the U.S. Food and Drug Administration
oversight of related products by the U.S. Food and Drug Administration
primary federal rules for FDA oversight of regulated products
hasAbbreviation 21 CFR Chapter I
jurisdictionOf U.S. Food and Drug Administration NERFINISHED
language English
legalAuthorityFor federal rules for FDA-regulated products
legalBasisFor FDA enforcement actions regarding drugs
FDA enforcement actions regarding food
FDA enforcement actions regarding medical devices
FDA enforcement actions regarding related products
partOf Title 21 of the Code of Federal Regulations NERFINISHED
regulates adulteration standards for FDA-regulated products
clinical investigation requirements for certain FDA-regulated products
good manufacturing practice requirements for FDA-regulated products
import and export of FDA-regulated products
labeling requirements for FDA-regulated products
misbranding standards for FDA-regulated products
post-market surveillance requirements for FDA-regulated products
pre-market approval processes for certain FDA-regulated products
registration and listing of establishments for FDA-regulated products
subjectOf federal regulatory compliance for FDA-regulated industries
titleNumber 21
usedBy FDA staff
compliance officers
regulated industry stakeholders
regulatory attorneys

Referenced by (1)

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Title 21 chapter Chapter I – Food and Drug Administration
subject surface form: Title 21 of the Code of Federal Regulations