Medical Device Weaponization: Section 232 Investigation

On September 26, 2025, the Department of Commerce published a notice requesting public comment on “an investigation to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices.” 90 Fed. Reg. 46383 (Sept. 26, 2025). The investigation was initiated on September 2, 2025, pursuant to section 232 of the Trade Expansion Act, which “allows the President to impose restrictions on goods imports or enter into negotiations with trading partners if the U.S. Secretary of Commerce determines, following an investigation, that the quantity or other circumstance of those imports ‘threaten to impair’ U.S. national security.”

This section 232 investigation certainly is not the first under the Trump administration and almost certainly will not be the last. Devices now find themselves in the company of copper, timber and lumber, semiconductors, pharmaceuticals, trucks, minerals, commercial aircraft and jet engines, polysilicon, unmanned aircraft systems, and wind turbines. Essentially any product regulated by FDA as a medical device is the subject of this investigation, though the notice breaks them down as follows:

• Personal protective equipment (PPE) such as surgical masks, N95 respirators, gloves, gowns, and related medical parts and components;
• Medical consumables including medical/surgical instruments such as syringes, needles, and infusion pumps, supplies such as IV bags, catheters, bandages, and diagnostic and lab reagents;
• Medical equipment, which refers to items such as carriages and wheelchairs, crutches, and hospital beds; and
• Medical devices generally, which tracks the definition in the FDCA and includes “any instrument, apparatus, or machine used in the diagnosis, monitoring, or treatment of medical conditions.” Examples provided include blood glucose monitors, pacemakers, heart valves, hearing aids, x-ray equipment, and MRI machines.

The notice requests comments and information related to potential national security risks associated with medical devices, including:

• Current and projected demand for devices in the United States;
• The extent to which domestic production of devices can meet the domestic demand;
• The role of foreign supply chains in meeting US demand;
• The concentration of US imports of devices from a small number of suppliers or countries and associated risks;
• The impact of “foreign government subsidies and predatory trade practices on the competitiveness” of medical device manufacturers in the US;
• The “economic impact of artificially suppressed prices” of medical devices “due to foreign unfair trade practices and state-sponsored overproduction”;
• The potential for export restrictions by other countries, “including the ability of foreign nations to weaponize their control over supplies” of medical devices;
• The feasibility of increasing domestic production of devices;
• The impact of current trade policies on domestic production of devices and whether tariffs or quotas “are necessary to protect national security”;
• The potential “for foreign control or exploitation of supply chains” for devices; and
• The “ability of foreign persons to weaponize the capabilities or attributes of foreign-built” devices.

The date by which comments must be submitted to the docket is October 17, a very short turnaround. Medical device manufacturers who import products or components from overseas should strongly consider submitting comments. Since implementation of tariffs or quotas under section 232 relies upon a finding of a threat to national security, those comments should establish a record indicating strength and oversight of the foreign supply chain, the systems in place to identify potential “weaponization” of imported devices, and the likely consequences to Americans of imposing tariffs or quotas on critical medical products.  Because the Section 232 investigation provides an opportunity for notice and comment, it may be more difficult to challenge the government’s imposition of these tariffs after this process has completed.

To date, we are not aware of any reason to believe that medical devices manufactured overseas pose, or have posed, a national security threat. Making this assessment will be a nuanced and challenging responsibility.  But if there is any lesson that can be drawn from the 100% tariffs that will go in effect on October 1 for pharmaceuticals, it is that there is room for many exemptions.  The drug tariffs are not going to impact generic drugs, which account for the vast majority of drugs imported to the U.S., nor will they apply to drug from the European Union, which already is subject to a much smaller 15% tariff.  There also is an exemption for those companies that have a U.S.-based manufacturing plant under construction.

Against this backdrop, it is timely that one of the authors of this post, Anne Walsh, an HPM Director and Co-Chair of the IBA Healthcare and Life Sciences Law Committee, is facilitating a panel titled “National security issues, such as biosecurity and supply chain impacts, related to the life science and healthcare sectors.”   Panelists will include Ravi Bharwani, from FDA’s Office of Global Policy and Strategy; Shannon Humphreys from Canada’s Investment Review Directorate; and in-house and outside counsel representing industry from all over the globe.  It will be an opportune and insightful discussion from the government and industry perspective.  Join Anne at the IBA Annual Conference in Toronto on November 4, 2025!