FDA Update

For In Vitro Diagnostic Test Developers:

Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web Pages Make Processes Clearer, Easier to Understand

The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and Medicaid Services (CMS) is responsible for many aspects of the CLIA program, including the certification of clinical laboratories, the U.S. Food and Drug Administration (FDA) is responsible for categorizing the complexity of tests, and the categorization is then used to determine which laboratories can perform which tests.

Learn more about:

• FDA’s role under the CLIA program
• FDA’s guidance documents on the FDA’s CLIA processes
• FDA’s process for test categorization
• Submitting a CLIA waiver application to the FDA

Questions?

For more information on surgical mesh for CLIA Web Pages please email us at: [email protected] and ref: CLIA Web Pages.