Premarket Approvals (PMA)
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated on a monthly basis.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "openFDA",
"@type": "vcard:Contact",
"hasEmail": "mailto:open@fda.hhs.gov"
}
|
| describedBy | http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135279.htm |
| description | Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated on a monthly basis. |
| distribution |
[
{
"@type": "dcat:Distribution",
"mediaType": "text/html",
"downloadURL": "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm"
}
]
|
| identifier | 475907fb-6a5d-4ad8-90c0-b276edc05227 |
| issued | 2021-02-25 |
| keyword |
[
"cdrh"
]
|
| landingPage | https://healthdata.gov/d/798x-p6ne |
| 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"
}
|
| references |
[
"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm",
"http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm"
]
|
| theme |
[
"FDA"
]
|
| title | Premarket Approvals (PMA) |
