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  1. IVD Regulatory Assistance

Public Databases

There are three ways to find out what categorization a laboratory test has received.

The CLIA Database, updated monthly, lists records of all commercially marketed laboratory tests that have been categorized under the Clinical Laboratory Improvement Amendments (CLIA), either by the Centers for Disease Control and Prevention (CDC) prior to January 31, 2000 or by the FDA since that date. Search the database by:

  • test system name
  • analyte name
  • complexity
  • specialty
  • date of categorization

Many of the records contain links to information about the CLIA parent document, such as:

  • 510(k) summary; or
  • PMA summary of safety and effectiveness.

Clinical Laboratory Improvement Amendments - Currently Waived Analytes provides a listing of all tests that are currently categorized as waived for any reason (i.e., by regulation, by marketing clearance/approval for over-the-counter use, or following an approved waiver by application). This listing is updated monthly.

The Over-The Counter Database provides a listing of all tests that are cleared or approved for over-the-counter use. Such tests are automatically categorized as waived. This database is updated monthly.


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