Vacated in March. Filed in September.

FDA’s own final rule, and FDA’s own final rule undoing it, both post to the Federal Register — dated, numbered, citable. The event in between — the one that actually ended the rule’s legal force — was a federal court’s order, and no primary source this pipeline or any registry-based one reads was ever built to carry a court docket.

A four-year phase-in, from a single amended clause

On May 6, 2024, FDA published a final rule titled Medical Devices; Laboratory Developed Tests (89 FR 37286), amending 21 CFR 809.3(a) to add nine words to the definition of an in vitro diagnostic product: “including when the manufacturer of these products is a laboratory.” That clause did the rule’s entire work. It pulled laboratory-developed tests inside the definition of a medical device for the first time, and phased in the ordinary device requirements — registration, listing, adverse event reporting, quality system compliance, and eventually premarket review — in stages running out to 2028.

The order that ended it carries no docket here

The American Clinical Laboratory Association and the Association for Molecular Pathology sued, consolidated as No. 4:24-cv-00479-SDJ in the Eastern District of Texas. On March 31, 2025, Judge Sean D. Jordan vacated the rule in its entirety under the Administrative Procedure Act, holding that FDA lacked statutory authority to regulate laboratory testing services — professional services performed inside a single laboratory, not products FDA introduces into interstate commerce — as devices at all. A vacatur under the APA doesn’t wait on FDA’s agreement or its announcement: the rule lost its legal force nationwide the day the order issued. No Federal Register document says so, because a district court order isn’t an FDA action, and it isn’t a category the Federal Register — or any of FDA Radar’s other sources — was ever built to carry.

The gap the codified text sat inside

eCFR’s copy of 21 CFR 809.3(a) doesn’t get corrected by a court ruling either — it moves only when FDA files something that says to move it. FDA didn’t file that something until September 19, 2025, when it published a final rule under RIN 0910-AJ05 reverting 809.3(a) to its pre-2024 text, effective the day it posted, with no notice-and-comment period, because it was conforming the regulation to a court order rather than making a new policy choice. For roughly five and a half months in between, the codified regulation on the page still read as though laboratory-developed tests were devices, while no court in the country would have enforced that reading against anyone.

The rule stopped applying in March. The record didn’t say so until September.

The practice

A portfolio holding product codes FDA had begun treating as laboratory-developed tests would have seen exactly two entries in FDA Radar’s Federal Register feed: the rule taking effect in May 2024, and the rule reverting it in September 2025, per what we monitor and how often. Nothing in that feed, or in the openFDA record behind it, would have marked the day in between when the underlying obligation actually stopped. A rule under active litigation is a standing reason to track the docket directly rather than wait for FDA’s own paperwork to catch up to the court’s; whether a specific compliance deadline was still live on a specific date during that gap is a determination for counsel reading the order itself, not a call this post is making. This is regulatory intelligence and method, never regulatory advice about any pending or past litigation’s effect on a specific device.