FDA Skips Move to Revive Suit Over Agency’s Lab Test Authority

The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate lab-developed tests, dealing a blow to the agency’s longstanding effort to control tests and ensure quality products.

The agency had until May 31 to file a notice of appeal to an order from Judge Sean D. Jordan of the US District Court for the Eastern District of Texas that determined the Food and Drug Administration’s final rule that allows it oversight of lab-developed tests (LDTs) is unlawful.

The agency’s move marks a major win for the American Clinical Laboratory Association and ...