CLIA Compliance
On February 28, 1992, the Department of Health and Human Services published laboratory standards regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
WHAT IS CLIA?
CLIA regulates laboratory testing and requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for the purpose of providing information; for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of the health of human beings.
There are different types of CLIA certifications a laboratory obtains depending upon the complexity of the tests it performs. CLIA regulations describe the following three levels of test complexity: waived tests, moderate complexity tests, and high complexity tests.
For more information, please visit the CDC website.
BECOMING CLIA CERTIFIED
We offer CLIA lab compliance from the ground-up! Please contact us for more information.
To do it yourself, you will need to complete some forms (can reach up to 20 forms depending on the state):
CMS-116
CMS-209
LAB-116
LAB-144
LAB-183
LAB-1513
A completed CLIA application is entered into a specific data system. A lockbox generates a bill which you will receive within two to three weeks. Once your payment is received (you may send it overnight express), it takes another two to three weeks to receive your certificate.
Upon receipt of a marketing application in the Center for Devices and Radiological Health (CDRH), the Food and Drug Administration (FDA) will automatically create a second discrete submission tracking number for the CLIA process and notify the sponsor of their CLIA Record (“CR”) number in addition to the tracking number for their premarket submission.
The FDA will assign a discrete CR number to this submission, notify the sponsor of the tracking number, and attempt to notify sponsors of the categorization within 30 days of the request. The FDA will also post the categorization in the public CLIA database with reference to the CR number.
To expedite review, the FDA strongly encourages submission of a validated eCopy per the Guidance Document “eCopy Program for Medical Device Submissions.”
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
