The Trump Administration has initiated national security investigations into imports of medical devices, industrial machinery, and robotics—a move that could trigger new tariffs and raise costs for manufacturers.

Launched Sept. 2 under Section 232 of the Trade Expansion Act of 1962, the probes are designed to determine whether higher tariff rates are necessary for various medical products like N95 respirators, syringes, surgical masks (and other PPE), coronary stents, heart valves, hearing aids, robotic and non-robotic prosthetics, blood glucose monitors, orthopedic appliances, electromedical apparatus (e.g., computed tomography scanners, magnetic resonance imaging machines); electrosurgical apparatus; X-ray apparatus/other radiation equipment, and MRI machines.

The investigation—which was not disclosed until Sept. 25—will assess current and projected demand for PPE, medical consumables, and medical devices; and whether domestic production can adequately meet that demand. The Commerce Department also is examining the role of foreign supply chains in meeting U.S. demand for medical devices and equipment, and the concentration of U.S. imports of PPE, devices, and equipment as well as associated risks.

In addition, businesses are urged to assess the effects of foreign government subsidies and potential predatory trade practices that could undermine the U.S. manufacturing sector. Comments on the investigation and its potential impacts on industry can be submitted to the Department of Commerce’s Bureau of Industry and Security (BIS), Office of Strategic Industries and Economic Security. The comments must be submitted by Oct. 17, according to the Department of Commerce notice.

The investigation’s outcome could have significant implications for the medtech industry, which fought for years to repeal a medical device tax created under the Affordable Care Act. The Trump administration has already used Section 232 of the Trade Expansion Act to impose levies on automobiles and parts, copper, steel, and aluminum.

Medtech industry executives fear new device tariffs would pose a serious threat to medical technology. AdvaMed, the MedTech Association, has repeatedly lobbied for a medical device tariff exemption; upon learning of the Section 232 investigation, the organization pledged to work with the Trump Administration to demonstrate the benefits of lower tariffs.

“Our industry is a uniquely American manufacturing success story and leads the world in medical innovation, providing American hospitals, doctors’ offices, and patients the highest-quality medical technologies in the world. Seventy percent of the medical products that American hospitals and patients rely on are made in America across thousands of manufacturing facilities in all 50 states,” AdvaMed President/CEO Scott Whitaker said. “Additionally, since 2019 medtech jobs have grown at three times the average manufacturing job rate, thanks in large part to sound tax policies, such as the OBBB, the TCJA, and the medical device tax repeal. We look forward to continuing our work with the Administration, including through the Commerce department’s investigation, to strengthen our already-robust and uniquely American industry. We believe this process will reinforce the fact that U.S. medtech manufacturing is strong and lower tariffs will fuel more manufacturing and job growth in the U.S., which means greater access to lifesaving technologies and lower costs to American hospitals and patients.” 

Earlier this year, the American Hospital Association warned the Trump Administration against imposing higher tariffs on America’s trade partners, noting, “the U.S. health care system relies significantly on international sources for many drugs and devices needed to both care for patients and protect healthcare workers. Tariffs, as well as any reaction of the countries on whom such tariffs are imposed, could reduce the availability of these life-saving medications and supplies in the U.S.”