FDA Clinical Laboratory Improvement Amendments Data -- FDA CLIA Data

This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.

"The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 244,000 laboratory entities."

"The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities."

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

The complete FDA Clinical Laboratory Improvement Amendments (CLIA) database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.

> 99.7% 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.

Source Data File
Clinical Laboratory Improvement Amendments (CLIA)

Contact data@nber.org with questions, comments, or suggestions.

Last Update Created by Jean Roth July 27, 2014

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