FDA Clinical Laboratory Improvement Amendments

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:

• Clinical Laboratory Improvement Amendments Data and More Information
• CLIA - Clinical Laboratory Improvement Amendments Searchable Database
• CLIA - Clinical Laboratory Improvement Amendments Overview
• FDA Premarket Notification 510(k) Database
• FDA Premarket Approval Application (PMA) Database

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.

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