Statements (51)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:appliesTo |
manufacturers
retailers distributors importers |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
US FDA regulations
|
| gptkbp:legalBasis |
gptkb:Public_Health_Service_Act
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act gptkb:Food_Safety_Modernization_Act 21 CFR |
| gptkbp:purpose |
protect public health
ensure safety and efficacy of products |
| gptkbp:regulates |
gptkb:food
biologics cosmetics drugs medical devices radiation-emitting products tobacco products |
| gptkbp:requires |
adverse event reporting
good manufacturing practices labeling requirements postmarket surveillance environmental impact assessment risk assessment ingredient disclosure product recalls nutrition labeling import/export controls child-resistant packaging recall procedures sanitation standards inspection of facilities advertising and promotion controls animal testing for safety clinical data submission clinical trials for new drugs electronic records and signatures import detention and refusal lot and batch control premarket approval for drugs premarket notification for devices registration of facilities traceability for food supply user fee payments warning statements |
| gptkbp:bfsParent |
gptkb:Medical_Device_Regulation
gptkb:ISO_14971:2019 |
| gptkbp:bfsLayer |
7
|