Topic
laboratory developed tests
46 published works
frESH
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug,…
Health Care and Life Sciences
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
By Jason Madden, Matthew J. Westbrook, D. Austin Rettew
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule…
Triage Health Law
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
By Keith Bradley, Delia Deschaine, Samuel Ballingrud
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug,…
Health Care and Life Sciences
LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court
By Dominick DiSabatino, Audrey Mercer
Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug…
Health Law Diagnosis
FDA Sued Over Laboratory Developed Tests Final Rule
By Danielle Tangorre, Guest Contributor
*This post was authored by Nicole Benevento, law intern at Robinson+Cole. Nicole is not admitted to practice law. The Food and Drug Administration (FDA) is being sued in two lawsuits after…
Health Care and Life Sciences
LDT Final Rule Series: Part 3 – Legal Challenges
By Scott Liebman, Dominick DiSabatino, Audrey Mercer
This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance…
Trends in Transformation
FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule
Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical…
Health Law
FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule
Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical…
Health Care and Life Sciences
LDT Final Rule Series: Part 2 – Response to the Rule
By Scott Liebman, Dominick DiSabatino, Audrey Mercer
In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) - which established a…
Life Sciences Perspectives
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests
By Brian Burgess|Steven Tjoe|Matt Wetzel|Benjamin Hayes
On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status…