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 once a week.
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Premarket Approvals (PMA)
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Complete Metadata
| @type | Dataset |
|---|---|
| accessRights | public |
| contactPoint |
[ { "fn": "FDA Governance Team", "@type": "Kind", "hasEmail": "mailto:uig@fda.hhs.gov" } ] |
| 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 once a week. |
| distribution |
[ { "@type": "Distribution", "title": "Premarket Approvals (PMA)", "accessService": [ { "@type": "DataService", "title": "Devicepma API", "publisher": { "name": "FDA", "@type": "Organization" }, "endpointURL": [ "https://api.fda.gov/device/pma" ], "contactPoint": [ { "fn": "open FDA", "@type": "Kind", "hasEmail": "mailto:open@fda.hhs.gov" } ], "endpointDescription": [ "https://api.fda.gov/device/pma.json" ] } ], "useRestriction": [ { "@type": "UseRestriction", "restrictionStatus": "unrestricted" } ] } ] |
| identifier | 0012-FDA-CDRH-PB-I-202608 |
| inventoried | 2026-09-27 |
| isPartOf | devicepma-api |
| keyword |
[ "Devices/ Pre-Market/ Approval" ] |
| publisher |
{ "name": "Center for Devices and Radiological Health (CDRH)", "@type": "Organization", "subOrganizationOf": [ { "name": "Food and Drug Administration (FDA)", "@type": "Organization", "subOrganizationOf": [ { "name": "U.S. Department of Health and Human Services", "@type": "Organization" } ] } ] } |
| status | Candidate |
| theme |
[ { "@type": "Concept", "prefLabel": "Devices" } ] |
| title | Premarket Approvals (PMA) |
