CLIA waived testsclia 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 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 a low risk to public health. 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.

CLIA Waived Device

The instruction sheet is what distinguishes a CLIA Waived device from an identical device, not CLIA Waived. Instruction sheets for CLIA Waived devices written in simple to understand language. It doesn’t contain technical jargon.  No difference in the device itself from a CLIA Waived device and a device that don’t have CLIA Waived status.

A device CLIA Waived do not require trained laboratory personnel to administer the test. Do not require costly laboratory quality control testing. The non-professional staff is permitted to use CLIA Waived tests. The cost of testing is more economical and can be performed timely by front-line staff.

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