FDA Premarket Approval Application

DOI https://doi.org/10.60592/p78j-xp08

Source U.S. Food and Drug Administration

"Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury."

The FDA offers many helpful, additional resources such as the following:

The complete FDA Premarket Approval Application (PMA) database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.

> 98% of all Premarket Approval Application records are all plain, ASCII characters.

Stata does not handle unicode characters well, so substitutions to ASCII characters have been made.

The SAS and CSV files are made from the Stata file. Non-ASCII characters can cause records to be dropped on conversion. So, check that that the number of observations ( see obs: in the desc file ) in the SAS and CSV file checks out. ( The CSV file has one line for each row of data plus one additional line for variable names ).

Updates and changes.