Clia FDA approved Clinical Laboratory Improvement Amendments, i.e., CLIA waived tests establishes quality standards for all laboratory testing to ensure the accuracy, reliability. Timeliness of patient test results. The FDA categorizes commercially marketed tests into one of three CLIA. Categories are according to the complexity and their potential for risk to public health:
- CLIA waived tests
- Tests of moderate complex
- Tests of high complex
CLIA Waived devices are the least complex. In order to receive status. A product maker must demonstrate that a device is simple to use, has a low risk to public health. An un qualify person can get perfect results by reading the instructions. By regulation, all devices that have FDA clearance for home and consumer use are automatically CLIA Waived.
CLIA Waived Device
The instruction sheet is what distinguishes a it device from an identical device, not device. Instruction sheets for devices written in simple to understand language. It doesn’t contain qualify jargon. No difference in the device itself from a device and a device that doesn’t have status.
A device does not require trained laboratory personnel to administer the test. Do not require costly lab quality control testing. The non-professional staff is permitted to use CLIA tests. The cost of testing more reasonable price and can perform timely by front line staff.