522 Postmarket Surveillance Studies
The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
Complete Metadata
| bureauCode |
[ "009:10" ] |
|---|---|
| identifier | 3d55fceb-5248-4475-b675-503312202d0d |
| issued | 2021-02-25 |
| landingPage | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm |
| programCode |
[ "009:005" ] |
| references |
[ "http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm268064.htm", "http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm" ] |
| theme |
[ "FDA" ] |
