FDA Center for Devices and Radiological Health

URI: https://gptkb.org/entity/FDA_Center_for_Devices_and_Radiological_Health
GPTKB entity
Statements (24)
Predicate Object
gptkbp:instanceOf gptkb:government_agency
gptkbp:abbreviation gptkb:CDRH
gptkbp:country gptkb:United_States
gptkbp:director gptkb:Jeffrey_Shuren
gptkbp:division gptkb:U.S._Department_of_Health_and_Human_Services
gptkbp:established 1976
gptkbp:headquartersLocation gptkb:Silver_Spring,_Maryland
https://www.w3.org/2000/01/rdf-schema#label FDA Center for Devices and Radiological Health
gptkbp:oversees postmarket surveillance of medical devices
premarket approval of medical devices
device adverse event reporting
device recalls
gptkbp:parentOrganization gptkb:U.S._Food_and_Drug_Administration
gptkbp:partOf gptkb:U.S._Food_and_Drug_Administration
gptkbp:regulates medical devices
electronic products emitting radiation
radiological health products
gptkbp:responsibleFor regulation of medical devices
regulation of radiation-emitting electronic products
gptkbp:website https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
gptkbp:bfsParent gptkb:Food_and_Drug_Administration_White_Oak_campus
gptkb:Emergency_Use_Authorization
gptkb:FDA_investigational_device_exemption_(2023)
gptkbp:bfsLayer 7