Device Pre-market Approval Overview

PMA is any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference. “PMA” includes a new drug application for a device under section 520(l) of the FD&C Act.

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.

For additional information, please visit the FDA's Premarket Approval (PMA) page.

Applicant

Key Facts

  • Source of the data:
  • Changes to the source data:
    openFDA annotates the original records with special fields and converts the data into JSON, which is a widely used machine readable format.
  • Time period covered in this API:
    1976 to present
  • Frequency of API updates:
    Monthly

Fields Harmonization

Different datasets use different unique identifiers, which can make it difficult to find the same device in each dataset.

openFDA features harmonization on specific identifiers to make it easier to both search for and understand the drug products returned by API queries. These additional fields are attached to records in all categories, if applicable.

Review the chart below to better understand which fields are harmonized.

Responsible use of the data

Do not rely on openFDA to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of FDA-regulated products. We may limit or otherwise restrict your access to the API in line with our Terms of Service