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NOTE: Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing authority to promulgate standards for certain laboratory testing to ensure the accuracy, reliability and timeliness of test results regardless of where or by whom the test was performed.
What is the difference between a CLIA and a FDA?
CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue. This is done for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.
Do research labs need to be CLIA certified?
All laboratory testing performed on humans in the United States, including research testing under the circumstances described here, is subject to the regulations called the Clinical Laboratory Improvement Amendment (CLIA). CLIA regulations require laboratories to be certified.
What is a CLIA billing?
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 accurate, reliable, and timely patient test results.
How does a laboratory enroll in the CLIA program?
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.
Recommendations for Dual 510(k) and CLIA Waiver by
Feb 26, 2020 The purpose of this guidance is to assist manufacturers in using the Dual 510(k) and Clinical. Laboratory Improvement Amendments (CLIA) Waiver
About this form. Use this form to pay your CLIA fees. Accepted Payment Methods: Bank account (ACH); Debit or credit card. Continue to the Form. Preview Form.
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