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FDA Urged To Moderate Evidence Requirements In LDT Framework

The agency will need to restrain evidence expectations for proving clinical validity in its planned framework for regulating laboratory-developed tests in order to make the framework more feasible, speakers at a Sept. 18 Avalere conference said.

FDA may have to moderate its data expectations for providing clinical validity of laboratory-developed tests if its newly planned framework is going to be feasible to implement, speakers at a Sept. 18 diagnostics policy conference said.

The framework would subject makers of LDTs, which are diagnostic services offered from the same lab in which the test is developed, to FDA premarket and postmarket regulatory requirements, on a risk-based schedule. Mandates would be directed first at the highest risk products and, over time, many high- and moderate-risk LDTs, with exceptions, would be subject to some type of premarket review

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