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.
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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 |
