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88 FR 68006 at 68008 (stating that “FDA has normally exercised enforcement discretion this sort of that it commonly has not enforced applicable prerequisites with respect to most LDTs”); 88 FR 68006 at 68009 (stating that “FDA has frequently considered an LDT to be an IVD that is intended for medical use and that's developed, produced, and applied in just a single laboratory which is certified under [CLIA] and meets the regulatory specifications beneath CLIA to conduct higher complexity testing”)). With regards into the definition of “diagnostic,” FDA interprets this comment like a ask for to further determine the phrase while in the definition of the IVD.
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