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FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests | FDA

On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be covered under the requirements of Food, Drug and Cosmetics Act. The FDA published this proposed rule on Federal Register on 3 October. This document is open for comments until 4 December.

Through this rule FDA intends to better protect public health, reduce healthcare costs associated with unsafe and ineffective LDTs and support innovation. More information on this rule can be found here.