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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
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "openFDA",
"@type": "vcard:Contact",
"hasEmail": "mailto:open@fda.hhs.gov"
}
|
| 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. |
| distribution |
[
{
"@type": "dcat:Distribution",
"mediaType": "application/vnd.ms-excel",
"downloadURL": "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas_Excel.cfm"
}
]
|
| identifier | 910c9a83-0447-4c05-b418-c2f49dd83b1b |
| issued | 2021-02-25 |
| keyword |
[
"cdrh"
]
|
| landingPage | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm |
| license | http://opendefinition.org/licenses/odc-odbl/ |
| modified | 2013-11-01 |
| programCode |
[
"009:005"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Post-Approval Studies |
