Section 232 tariff investigation: What medical device manufacturers and importers need to know

The legal foundation

Section 232 of the Trade Expansion Act of 1962 gives the President broad authority to adjust imports if they are found to threaten national security. Historically, this provision has been used for items like steel and aluminum, and applying it to medical devices and related products is novel. In the past, the Trump Administration has used its authority under Section 232 to impose tariffs ranging as high as 50%, as well as quotas, and has threatened even higher tariffs on certain products. The investigation at issue covers a wide range of products: personal protective equipment (PPE), medical consumables, and durable medical equipment—including everything from surgical masks and gloves to pacemakers, imaging machines, and prosthetics.

Why is this happening now?

The COVID-19 pandemic exposed vulnerabilities in the U.S. healthcare supply chain, particularly the reliance on foreign sources for critical medical products, such as N95 and KN95 masks and similar PPE. The government is now asking whether this reliance poses a national security risk, either now or in the event of any future health emergency, especially if foreign governments could restrict exports or manipulate prices. The investigation seeks public input on whether current trade policies are sufficient, or if new measures—such as tariffs or quotas—are needed to protect domestic manufacturing and supply.

What is the government seeking public comment on?

As legal counsel, we urge medical device manufacturers and importers to pay close attention to the specific issues on which the Department of Commerce is inviting public comment in this Section 232 investigation. The government is not simply asking for general opinions—it is seeking detailed, data-driven input on a range of factors that will shape the outcome of this process.

Specifically, the Department is requesting comments and information on:

• Current and projected demand: What is the present and future need for PPE, medical consumables, and medical devices in the United States? Are there anticipated surges or shortages?
• Domestic production capacity: Can U.S. manufacturers meet domestic demand for these products? Where are the supply and demand gaps, and what are the barriers to scaling up production to meet demand?
• Foreign supply chains: How reliant is the U.S. on foreign suppliers, especially major exporters? Is there a concentration of imports from a small number of countries?
• Foreign government subsidies and trade practices: Are foreign governments subsidizing their industries or engaging in predatory trade practices that undermine U.S. competitiveness?
• Artificially suppressed prices: Is there evidence that foreign unfair trade practices or state-sponsored overproduction are driving down prices in ways that harm U.S. manufacturers?
• Export restrictions and weaponization: Could foreign nations restrict exports or weaponize their control over supplies, threatening U.S. access to critical medical products?
• Feasibility of increasing domestic capacity: What would it take to boost U.S. production and reduce reliance on imports? Are there practical or economic obstacles?
• Impact of current trade policies: How do existing trade policies affect domestic production? Are additional measures—such as tariffs or quotas—necessary to protect national security?
• Supply chain control and exploitation: Is there a risk of foreign control or exploitation of the supply chains for these products?
• Potential for weaponization of foreign-built devices: Could foreign-built medical devices be used in ways that compromise U.S. security or the safety of U.S. citizens?
• Other relevant factors: The Department welcomes any other information that could inform its assessment of national security risks related to medical device imports.

Why does this matter?

The Department will use these comments to determine whether new trade measures are warranted. Manufacturers who provide robust, evidence-based input can help ensure that any resulting policies are balanced, effective, and do not inadvertently harm patient care or innovation.

What should manufacturers be doing?

1. Assess your supply chain risks. From a regulatory perspective, FDA compliance depends on reliable access to components and finished devices. Manufacturers should map their supply chains, identify single points of failure, and consider how tariffs or quotas could disrupt operations. If your products rely heavily on imports from a small number of countries, you may be at greater risk.
2. Prepare to engage in the comment process. The Department of Commerce is soliciting public comments on a range of issues, including domestic production capacity, the impact of foreign subsidies, and the feasibility of increasing U.S. manufacturing. Manufacturers and importers should consider submitting data and analysis to help shape the investigation's outcome. If you have evidence that tariffs would harm patient access or innovation, now is the time to make your case. Comments are due soon, by October 17, 2025.
3. Understand the regulatory and trade implications. If the investigation results in new tariffs or quotas, manufacturers will need to quickly adapt. This could mean shifting supply chains, renegotiating contracts, or even redesigning products to source more components domestically. From a trade law perspective, Section 232 actions can be challenged by trading partners under World Trade Organization rules and may provoke retaliatory measures affecting U.S. exports.
4. Protect confidential business information. If you submit comments, be sure to follow the Department's instructions for marking business confidential information. This protects sensitive data from public disclosure and ensures your concerns are considered appropriately.

Looking ahead

The Section 232 investigation is a reminder that trade and regulatory issues are increasingly intertwined for medical device manufacturers and importers. We recommend that companies:

• Stay informed about the investigation’s progress via the Federal Register and regulations.gov (search for BIS-2025-0258).
• Work with legal counsel to assess risks and prepare advocacy strategies.
• Coordinate with industry groups to present a unified position.

Ultimately, the outcome of this investigation could reshape the landscape for medical device imports and domestic production for the foreseeable future. Manufacturers who proactively assess their risks, engage in the process, and prepare for change will be best positioned to navigate whatever comes next.

Next steps: Connect with us

Understanding the full implications of the Section 232 tariff investigation for your business is critical—especially given the potential for new trade barriers, supply chain disruptions, and regulatory impacts. As attorneys who specialize in FDA medical device regulation and international trade law, we are ready to help you:

• Assess how the investigation and possible tariffs or quotas could affect your operations, costs, and compliance strategies.
• Develop and submit effective public comments to the Department of Commerce, ensuring your voice is heard in this process.
• Map supply chain vulnerabilities and prepare risk mitigation strategies.
• Coordinate advocacy efforts with industry groups and stakeholders.

If you have questions about how this investigation may impact your company, or if you need assistance preparing a comment or understanding the legal and business risks, please reach out to us. Early engagement can help you protect your interests and shape the future of medical device trade policy.

Contact us today to schedule a consultation or to discuss how we can support your business through this evolving regulatory landscape. Your proactive involvement is essential—and we’re here to guide you every step of the way.

Authored by Jodi Scott, Nicholas Sparks, and Wil Henderson