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. More information on this rule can be found here.
The FDA will host a webinar on 31 October to provide information on the proposed rule regarding Laboratory Developed Tests or LDTs. More information on this webinar can be found here.