{"@type": "dcat:Dataset", "accessLevel": "public", "bureauCode": ["009:10"], "contactPoint": {"@type": "vcard:Contact", "fn": "openFDA", "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", "downloadURL": "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas_Excel.cfm", "mediaType": "application/vnd.ms-excel"}], "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": {"@type": "org:Organization", "name": "U.S. Food and Drug Administration"}, "theme": ["FDA"], "title": "Post-Approval Studies"}