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Device Pre-market Approval

api.fda.gov/device/pma

The PMA dataset contains details about specific products and the sponsors of premarket approval applications and supplements. It also contains administrative and tracking information about the applications and receipt and decision dates. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. An approved PMA Application is, in effect, a private license granted to the applicant for marketing a particular medical device.

BasicsReference guide

About device pre-market approval

The PMA dataset contains details about specific products and the sponsors of premarket approval applications and supplements. It also contains administrative and tracking information about the applications and receipt and decision dates. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. An approved PMA Application is, in effect, a private license granted to the applicant for marketing a particular medical device.

Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices.

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Reference

See the comprehensive field-by-field reference for more detail about the structure and contents of device pre-market approval.

How to search this endpoint

Make API calls to https://api.fda.gov/device/pma.json using search parameters for fields specific to the device PMA endpoint.

Example API query

One PMA record with the decision_code equal to APPR

This query searches for all records with a particular decision_code.

  1. search for all records with decision_code equal to APPR.

  2. limit to 1 record.

Example API query

One PMA record for the LWP product code

This query searches for records matching a certain search term, and asks for a single one.

See the reference for more fields you can use to count and understand the nature of device PMA approval.

  1. search for all records with product_code equals LWP.

  2. limit to 1 record.

Example API query

Count of top advisory committees for PMA submissions.

This query is similar to the prior one, but returns a count of the most frequent advisory committees.

See the reference for more fields you can use to count and understand the nature of device PMA approval.

  1. search for all records.

  2. count the field advisory_committee