Clinical Laboratory Improvement Amendments (CLIA) establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. The FDA categorizes commercially marketed tests into one of three CLIA categories according to complexity and their potential for risk to public health:
- Waived tests
- Tests of moderate complexity
- Tests of high complexity
CLIA Waived devices are the least complex. In order to receive CLIA Waived status, a manufacturer must demonstrate that a device is simple to use, has low risk to public health, and that an untrained person can get accurate results by reading the instructions. By regulation, all devices that have FDA clearance for home and consumer use are automatically CLIA Waived as well.
The instruction sheet is what distinguishes a CLIA Waived device from an identical device that is not CLIA Waived. Instruction sheets for CLIA Waived devices are written in simple to understand language and do not contain technical jargon. There typically is no difference in the device itself from a CLIA Waived device and a device that does not have CLIA Waived status.
A device that is CLIA Waived does not require highly trained laboratory personnel to administer the test and does not require costly laboratory quality control testing. Because non-professional staff is permitted to use CLIA Waived tests, the cost of testing is more economical and can be performed more timely by front-line staff.
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