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- FDA LDT rule rescinded
The Food and Drug Administration (FDA) has formally rescinded the laboratory-developed tests (LDT) rule following a court decision, with regulatory review pending.
The rescission is a pro forma action, in compliance with a US District Court ruling that nullified the FDA’s regulation on the oversight of LDTs.
- Since the FDA did not move to appeal the decision vacating the LDT final rule, the rescission is largely a formality.
What's next: The rescission is pending regulatory review by the Office of Information and Regulatory Affairs (OIRA) pursuant to Executive Order 12866, and a formal notice in the Federal Register is expected within sixty days.