National Security Investigation: Imports Of Personal Protective Equipment, Medical Consumables, And Medical Equipment, Including Devices

On September 2, 2025, the U.S. Department of Commerce's Bureau of Industry and Security (BIS) initiated an investigation to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment, including devices to determine the effect imports of these products pose to U.S. national security.¹ This investigation could lead to the imposition of tariffs on covered PPE, medical consumables, equipment and devices similar to the 25% section 232 tariffs on steel articles, aluminum articles, and their derivatives that became effective on March 12, 2025.

BIS has identified a broad range of products that are subject to investigation, including:

• Personal protective equipment: PPE used in health care settings. PPE includes, but is not limited to:
• • Surgical masks;
  • N95 respirators;
  • Gloves;
  • Gowns; and
  • Related medical parts and components.

• Medical consumables: Single-use or short-term-use items used for patient diagnosis, treatment, and prevention of conditions. Medical consumables include but are not limited to:
• • Medical/surgical instruments (e.g., syringes, needles, infusion (IV) pumps, forceps, scalpels);
  • Medical/surgical supplies (e.g., intravenous (IV) bags, catheters, tracheostomy tubes, anesthesia equipment, gauze/bandages, sutures, diagnostic and laboratory reagents); and
  • Related medical parts and components.

• Medical equipment: Refers broadly to durable equipment, tools, and machines used in healthcare to support patient care. Examples include, but are not limited to:
• • Carriages and wheelchairs;
  • Crutches; and
  • Hospital beds.

• Medical devices: Any instrument, apparatus, or machine used in the diagnosis, monitoring, or treatment of medical conditions. Examples include, but are not limited to:
• • Pacemakers;
  • Insulin pumps;
  • 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;
  • Respiratory machines (e.g., ventilators, respirators, oxygen apparatus); and
  • MRI machines

Notably, pharmaceuticals, such as prescription drugs, over-the-counter drugs, biologics, and specialty drugs, will not be covered under this investigation as BIS is examining those imports in a separate Section 232 investigation. It is also important to note that there remains some uncertainty with respect to global tariff treatment of certain products. For example, on September 25, 2025, the Administration issued a notice entitled Implementing Certain Tariff-Related Elements of the U.S.-EU Framework on an Agreement on Reciprocal, Fair, and Balanced Trade, which stated that only the most-favored-nation tariff will apply to certain goods from the European Union, such as generic pharmaceuticals, their ingredients and chemical precursors.² Accordingly, it will remain important for companies to stay abreast of negotiations and corresponding modifications to tariffs.

Nevertheless, the section 232 investigation into PPE, medical consumables, and medical equipment and devices covers a broad range of imports and inputs, many of which are not currently produced in significant quantities in the United States, if at all. As such, this investigation could have a widespread impact across the entire healthcare sector.

Generally, national security investigations conducted under section 232 of the Trade Expansion Act require the Commerce Department to reach its determination within 270 days.³ At the conclusion of the investigation, Commerce will report its findings to the President on whether imports of PPE, medical devices, or medical equipment into the United States threaten national security. Previous investigations' reports have also provided recommendations on actions to mitigate such threats, including potential tariffs, export controls, or incentives to increase domestic production; and policy recommendations for strengthening the United States domestic and friend-shored supply chain through strategic partnerships, industrial incentives or investments, and regulatory reforms.

Importantly, for most of the factors Commerce will be investigating, the U.S. industry is best situated to provide information on the U.S. domestic industry's macro- and micro-economic conditions, as well as challenges experienced during the course of business. Significantly, as with Commerce's past section 232 investigations on steel, aluminum, critical minerals, and automobiles and automotive parts, Commerce has now invited interested parties to comment. On September 26, 2025, BIS issued a notice requesting interested parties submit comments, data, or other information to help guide the investigation.⁴ Interested parties will have until October 17, 2025, to submit comments, which may be public or confidential.⁵ Accordingly, for companies that may be affected by this investigation, it is important to understand the issues early and develop a strategy to best serve your interests.

Buchanan has a team of international trade and national security attorneys, life sciences and regulatory attorneys, economists, accounting analysts, and government relations professionals ready to help U.S. manufacturers with U.S. law at the intersection of trade and life sciences, as well as related policy. Our dedicated team has decades of experience supporting clients across a range of industries – ranging from chemicals, agricultural products, synthetics, minerals, medical equipment – to protect U.S. companies against unfair trade.

Footnotes

1 Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, and Medical Equipment, Including Devices, 90 FR 46383 (September 26, 2025) (Request for Comments)

2 Implementing Certain Tariff-Related Elements of the U.S.-EU Framework on an Agreement on Reciprocal, Fair, and Balanced Trade, 90 Fed. Reg. 46,136 (Sept. 25, 2025); see also U.S. Customs and Border Protection, Cargo Systems Messaging Service # 66336270 - Guidance – Implementation of Tariff-Related Elements of the United States-European Union Framework Agreement (Sept. 24, 2025).

3 19 U.S.C. § 1862.

4 Request for Comments at 46383

5 Id.

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