FDA Issues Guidance With LDTs as Medical Devices Rule About to Take Effect

With FDA’s new regulation of laboratory developed tests (LDT) that becomes effective July 5, the agency has issued a final guidance intended to help small entities comply.

The guidance provides detailed information on the phasing out of FDA’s general enforcement discretion approach for LDTs so that they will generally fall under the same enforcement approach as other in vitro diagnostics (IVDs).

The guidance, “Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff,” says that the phaseout policy should “better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.”

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