Center for Devices and Radiological Health
E88388
The Center for Devices and Radiological Health is the U.S. FDA division responsible for regulating medical devices and radiation-emitting products to ensure their safety and effectiveness.
All labels observed (5)
How this entity was disambiguated
This entity first appeared as the object of triple T686646 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Center for Devices and Radiological Health Context triple: [Food and Drug Administration, hasDivision, Center for Devices and Radiological Health]
-
A.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
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B.
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
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C.
Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
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D.
National Center for Toxicological Research
The National Center for Toxicological Research is a U.S. federal research facility that conducts scientific studies to support the safety evaluation and regulatory decisions of the Food and Drug Administration.
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E.
Bureau of Health Care Safety and Quality
The Bureau of Health Care Safety and Quality is a division of Massachusetts state government responsible for overseeing and improving the safety, quality, and regulatory compliance of health care facilities and services.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Center for Devices and Radiological Health Target entity description: The Center for Devices and Radiological Health is the U.S. FDA division responsible for regulating medical devices and radiation-emitting products to ensure their safety and effectiveness.
-
A.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
-
B.
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
-
C.
Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
-
D.
National Center for Toxicological Research
The National Center for Toxicological Research is a U.S. federal research facility that conducts scientific studies to support the safety evaluation and regulatory decisions of the Food and Drug Administration.
-
E.
Bureau of Health Care Safety and Quality
The Bureau of Health Care Safety and Quality is a division of Massachusetts state government responsible for overseeing and improving the safety, quality, and regulatory compliance of health care facilities and services.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
FDA center
ⓘ
regulatory agency division ⓘ |
| abbreviation |
CDRH
ⓘ
linked to:
Center for Devices and Radiological Health
|
| country |
United States
ⓘ
linked to:
United States of America
|
| goal |
ensure effectiveness of medical devices
ⓘ
ensure safety of medical devices ⓘ protect the public from unnecessary radiation exposure ⓘ |
| jurisdiction |
United States market for medical devices
ⓘ
imported medical devices into the United States ⓘ |
| language | English ⓘ |
| locatedIn | Silver Spring, Maryland ⓘ |
| parentOrganization |
U.S. Food and Drug Administration
ⓘ
linked to:
Food and Drug Administration
|
| partOf |
U.S. Food and Drug Administration
ⓘ
linked to:
Food and Drug Administration
|
| regulates |
CT scanners
ⓘ
MRI systems ⓘ consumer radiation-emitting products ⓘ diagnostic imaging equipment ⓘ implantable medical devices ⓘ in vitro diagnostic devices ⓘ laser products ⓘ mammography equipment ⓘ medical devices ⓘ radiation therapy equipment ⓘ radiation-emitting electronic products ⓘ therapeutic radiation devices ⓘ ultrasound devices ⓘ x-ray equipment ⓘ |
| responsibleFor |
classification of medical devices
ⓘ
combination product review in coordination with other FDA centers ⓘ digital health device oversight ⓘ enforcement of medical device regulations ⓘ guidance documents for medical device manufacturers ⓘ human factors review of medical devices ⓘ inspection of medical device manufacturers ⓘ mammography quality standards enforcement ⓘ medical device adverse event reporting systems ⓘ medical device effectiveness evaluation ⓘ medical device innovation support ⓘ medical device recalls oversight ⓘ medical device safety monitoring ⓘ postmarket surveillance of medical devices ⓘ premarket review of medical devices ⓘ radiation safety standards for electronic products ⓘ radiological health programs ⓘ software as a medical device oversight ⓘ |
| sector |
medical device regulation
ⓘ
public health ⓘ |
| website | https://www.fda.gov/about-fda/center-devices-and-radiological-health ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Center for Devices and Radiological Health Description of subject: The Center for Devices and Radiological Health is the U.S. FDA division responsible for regulating medical devices and radiation-emitting products to ensure their safety and effectiveness.
Referenced by (11)
Full triples — surface form annotated when it differs from this entity's canonical label.
Center for Drug Evaluation and Research
→
collaboratesWith
→
Center for Devices and Radiological Health
ⓘ
linked to: Center for Devices and Radiological Health
Nixon Reorganization Plan creating EPA
→
transferredProgram
→
Bureau of Radiological Health (certain functions)
ⓘ
linked to: Center for Devices and Radiological Health
White Oak, Maryland
→
isNearFederalFacility
→
U.S. Food and Drug Administration Center for Devices and Radiological Health
ⓘ
linked to: Center for Devices and Radiological Health
Food and Drug Administration Safety and Innovation Act of 2012
→
affectsAgency
→
Center for Devices and Radiological Health
ⓘ
U.S. Food and Drug Administration Office of Medical Products and Tobacco
→
oversees
→
Center for Devices and Radiological Health
ⓘ
U.S. Food and Drug Administration Office of Pediatric Therapeutics
→
collaboratesWith
→
FDA Center for Devices and Radiological Health
ⓘ
linked to: Center for Devices and Radiological Health