Medical Economics April 3, 2025
Chris Mazzolini

Key Takeaways

  • The medical device industry opposes new tariffs, fearing negative impacts on innovation, job loss, and increased healthcare costs, and is advocating for exemptions.
  • Significant layoffs at the FDA, including in the Center for Devices and Radiological Health, have raised concerns about slowed device approvals and reduced innovation.
  • Device clearances have decreased significantly in 2025 compared to 2024, with fewer de novo and premarket approvals, indicating potential disruption in the regulatory process.

Between President Trump’s tariff plan and sweeping layoffs at the FDA and HSS, the medical device industry is facing an uncertain future.

This week, President Donald J. Trump unleashed regulator layoffs and then global tariffs. The medical device industry is not happy.

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