About FDA

Premarket Approval (PMA) Clinical Trials Database

The Clinical Trials Database is a standardized dataset of information about the clinical studies and trials conducted in support of Premarket Approval (PMA). When complete, it will be able to be used by patients, healthcare providers, researchers and manufacturers to gain more knowledge about individual products.

The PMA Clinical Trials Database is abstracted from Premarket Approval (PMA) Summaries of Safety and Effectiveness data (SSED). It contains information regarding:

  • Marketing history of the device
  • Study design
  • Select demographics of study participants
  • Study follow-up
  • Study results

The documents on this page include:

  • A data dictionary that defines the data elements in the spreadsheet
  • A detailed description of the PMA Clinical Trials Database that is in development
  • A Sample Clinical Trials Database with data from 3 individual PMAs

 

In the future, FDA plans to integrate clinical trials data with information from the TPLC Database. The list below contains two examples of how the data might be presented in the future. Please note that these documents are only examples and do not contain current information.

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Page Last Updated: 05/19/2015
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