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Healthcare › Laboratory Developed Tests › Centers for Medicare & Medicaid Services (CMS)

Epstein Becker & Green

Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®

Epstein Becker & Green on

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Sheppard Mullin Richter & Hampton LLP on

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 Administration’s (“FDA’s” or the...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

McDermott+

McDermottPlus Check-Up: May 17, 2024

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House Energy & Commerce Health Subcommittee Advances 21 Bills. The markup included legislation around telehealth, Medicaid, workforce and rare diseases. Of note, the subcommittee advanced a bill that included an extension of...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

Akin Gump Strauss Hauer & Feld LLP on

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

McDermott+

Looking Forward: Top Policy Areas for 2024

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Happy New Year! As we enter 2024, we want to lay out some of the main regulatory issues (both new and old) that McDermott+Consulting will be tracking over the next year. While these may evolve, we think they are still...more

Foley & Lardner LLP

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

Foley & Lardner LLP on

After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

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THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Mintz

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

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Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

Foley & Lardner LLP

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

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Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

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