AdvaMed CEO Addresses Tariff Concerns and FDA Staff Cuts Amid Government Shutdown

What's Happening?

At the annual MedTech Conference, AdvaMed CEO Scott Whitaker discussed the challenges facing the medtech industry, including potential tariffs, FDA staff cuts, and the ongoing government shutdown. The Trump administration has initiated a Section 232 investigation into medical equipment, raising concerns about possible tariffs similar to those imposed on other industries. Whitaker emphasized the need for certainty in tariff policies, noting that high levies could significantly impact the industry and jobs. He also addressed FDA staff cuts, which have affected the Center for Devices and Radiological Health, although product review times have remained stable.

Why It's Important?

The medtech industry is a critical component of the U.S. healthcare system, and uncertainty in trade and regulatory policies could have far-reaching effects. Tariffs on medical equipment could increase costs for manufacturers and healthcare providers, potentially leading to higher prices for consumers and affecting access to medical devices. FDA staff cuts may delay device approvals, impacting innovation and the availability of new technologies. The ongoing government shutdown adds another layer of uncertainty, with potential disruptions to FDA operations and device submissions. The industry's call for clarity highlights the need for stable policies to support growth and innovation.

What's Next?

AdvaMed plans to file comments on the Section 232 investigation, advocating for the medtech industry's strong U.S. manufacturing footprint and trade surplus. The organization is seeking clarity from the administration on future tariff policies to allow companies to plan accordingly. The FDA's ability to manage device submissions during the shutdown remains a concern, although user fee-funded activities continue. The industry is closely monitoring the situation, with potential impacts on supply chains and production strategies. AdvaMed's efforts to engage with policymakers aim to mitigate risks and ensure continued stability in the medtech sector.