CLIA Waived Test Kits
|The FDA policy specified that CLIA waived tests are the simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
Now the CLIA waiver requirements are corrected and this is clear that test devices approved for home use by the Food and Drug Administration mechanically become the CLIA waived. Professional use versions of home use tests are not automatically waived. On the other hand, professional edition of such test kits do become qualified for simple waiver evaluation if the only differences between tests versions need to be studied to conclude whether the professional version qualifies for waiver.|
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