CLIA vs QSR (What You Don’t Know Can Hurt You)

The Clinical Laboratory Improvement Amendments (CLIA)established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.

This two-part series will discuss the ramifications and realities of the FDA’s increased interest in laboratory developed tests (LDTs) in CLIA laboratories.  CLIA labs and the tests that they develop and offer have largely gone untouched by the FDA until recently (we did not say unnoticed….).  Recent draft guidance issued by the FDA (FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs); Oct 2014) reaffirms the FDA’s interest in these tests and their awareness of this segment of the industry.

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CLIA vs QSR (What You Don’t Know Can Hurt You) 2016-02-04T09:18:00-08:00 Rating: 4.5 Diposkan Oleh: Unknown