Post-Approval Studies
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
Complete Metadata
| bureauCode |
[ "009:10" ] |
|---|---|
| identifier | 910c9a83-0447-4c05-b418-c2f49dd83b1b |
| issued | 2021-02-25 |
| landingPage | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm |
| programCode |
[ "009:005" ] |
| theme |
[ "FDA" ] |
