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.
Aliases (1)
- CDRH ×1
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
FDA center
→
regulatory agency division → |
| abbreviation |
CDRH
→
|
| country |
United States
→
|
| 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
NERFINISHED
→
|
| parentOrganization |
U.S. Food and Drug Administration
→
|
| partOf |
U.S. 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
→
|
Referenced by (3)
| Subject (surface form when different) | Predicate |
|---|---|
|
Center for Devices and Radiological Health
("CDRH")
→
|
abbreviation |
|
Center for Drug Evaluation and Research
→
|
collaboratesWith |
|
Food and Drug Administration
→
|
hasDivision |