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Regulatory Reform › Constitutional Challenges › Medical Devices

A&O Shearman

Italian Medical Device Payback: Italy approves 75% reduction on medical device payback to end disputes

A&O Shearman on

Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more

Epstein Becker & Green

A Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices

Epstein Becker & Green on

As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more

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