The CLIA application (Form CMS-116) collects information about your laboratory’s operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory …
How to apply for a CLIA Certificate and other information
This page provides information on how to apply for a CLIA certificate and additional information on what to expect after submittal.
Through the Clinical Laboratory Improvement Amendments (CLIA) Program, CMS regulates all lab testing (with some specific exceptions and state exemptions) done on humans in the U.S. to ensure …
How to Apply for CLIA Certification – Filling out CMS-116
Feb 14, 2025 · What are the next steps in the process to apply for a CLIA license? Here's an overview of how to apply for a CLIA certificate by filling out the CMS-116 form.
Clinical Laboratory Improvement Amendments (CLIA)
Instructions on how to apply for a clinical laboratory registration or license and federal CLIA certificate for waived, provider performed microscopy procedures, moderate or high complexity testing are found …
Clinical Laboratory Improvement Amendment (CLIA) Frequently Asked ...
Sep 10, 2025 · For changes in ownership, fill out the Centers for Medicaid and Medicare Services (CMS) 116 form with a cover letter indicating your CLIA number and the effective date.
How to Apply for and Get a CLIA Number - LegalClarity
Aug 27, 2025 · Learn how to apply for and successfully obtain your CLIA number. This guide details the entire process, from understanding needs to compliance.
The CLIA application (Form CMS-116) collects information about your laboratory’s operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory …
Clinical Laboratory Improvement Amendments (CLIA) | FDA
This page contains information about The Clinical Laboratory Improvement Amendments (CLIA) that regulate laboratory testing.
Getting CLIA-Certified: The Application and Inspection Process
Feb 13, 2025 · Get CLIA-certified with confidence. Learn how to navigate applications, inspections & more to ensure your labmeets federal standards for diagnostic testing.