THIS FORM MUST BE COMPLETED EVERY YEAR WITH CURRENT TEST DATA FOR STATE ACCREDITATION 2025

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Can I transfer my CLIA certificate to the new owners? Yes. The new owners can request a transfer by completing a CMS-116 Application Form and a CLIA Ownership Information form found under CERTIFICATION FEES on webpage.
Clinical Laboratory Improvement Amendments (CLIA) Section This process involves compliance with the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988, which requires that all laboratories testing human specimens be certified by the federal government. The Los Angeles LFS Office manages the CLIA program.
Forward your completed application to the address of the local State Agency for the State in which your laboratory is located. A list of State Agencies is available at the web site listed above.
The CLIA application (Form CMS-116) collects information about your laboratorys operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facilitys laboratory operation.
Professional Licensing: If you are looking for a certificate of waiver in a professional context (e.g., licensing for healthcare or legal professions), the relevant state licensing board or regulatory agency would provide the application. Each profession has its governing body that oversees compliance and regulations.
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You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available online at .cms.hhs.gov/clia or from your local State Agency. Forward your completed application to the address of the local State Agency for the State in which your laboratory is located.
Explanation: The first step for CLIA waived tests is to obtain a CLIA Certificate. CLIA, or the Clinical Laboratory Improvement Amendments, regulates laboratory testing and requires facilities to have a certificate in order to perform certain types of tests.
FDA Actions on CLIA Waiver by Application Submission ActionReview Time (FDA days) Substantive Interaction 90 days MDUFA Decision No Panel With Panel 150 320 Dual (510(k) and CLIA Waiver by Application 180 Feb 29, 2024

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