FDA oversight does not guarantee the reliability and validity of clinical tests (as well as the safety and effectiveness of drugs in humans).
Please check this information: http://chaoticpharmacology.com/2015/02/11/fda-research-misconduct-part-ii-further-comments-about-dabigatran-pradaxa/
Laboratory Developed Tests
Questions about the accuracy and marketing of Laboratory Developed Tests (LDTs) have led to the current debate whether the U.S. Food and Drug Administration (FDA) should regulate a subset of diagnostic tests currently exempted from oversight. Designed to bring clinical tests to market that the costly FDA process would otherwise preclude, such as those for rare diseases, the LDT pathway bypasses Federal regulation and accountability. Questions about the validity of these tests have raised concerns over patient safety and a call for oversight. Among those asking for regulation are Massachusetts Senators Edward J. Markey and Elizabeth Warren.
Opponents of regulation argue the LDT pathway enables new and pioneering tests to be developed quickly and improve patient care. A recent viewpoint piece published in JAMA opposing regulation noted such advances have occurred “in large part because of the nimbleness of relatively small clinical and academic laboratories that can quickly respond to new…
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