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US FDA publishes guidance on CLIA waivers

This article was originally published in Clinica

Executive Summary

The US FDA has published revised guidance for device manufacturers seeking to get their products waived from regulatory oversight under the Clinical Laboratory and Improvement Amendments of 1988 (CLIA) law. In the regulations published to implement the CLIA in 1992, waived tests were defined as simple laboratory examinations and procedures that were cleared by the FDA for home use, or that employ methodologies that -are simple and accurate as to render the likelihood of erroneous result negligible", or that pose no reasonable risk of harm to the patient if the test is performed incorrectly.

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