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Final Rules › Medical Devices › Regulatory Reform

Epstein Becker & Green

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

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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

Jones Day

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

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The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

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On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

Faegre Drinker Biddle & Reath LLP on

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

Stinson LLP

FDA Finally Finalizes the Intended Use Rule

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Last week, FDA published its new final rule amending the “intended use” regulations for drugs and medical devices, which it hopes will “put to rest any dispute” about the agency’s interpretation of evidence relevant to...more

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