Description
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.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| MS Excel File | XLS | pma_pas_Excel.cfm | Open resource |