Share Comments on Section 232 Investigation
HME Stakeholders Strong Encouraged to Share Comments by Oct. 17
On Sept. 26, 2025, the U.S. Department of Commerce initiated a Section 232 National Security Investigation into broad imports of medical equipment, devices, and consumables. This sweeping
review covers a wide range of products related to DME, including wheelchairs, hospital beds, portable oxygen concentrators, blood glucose monitors, IV bags, catheters, personal protective
equipment, and other items.
The investigation could result in tariffs, quotas, or other trade restrictions as early as 2026, with the stated goal of reducing reliance on devices manufactured outside of the U.S. and on
foreign supply chains. It is important for all DME stakeholders, including suppliers, manufacturers and distributors, to submit comments opposing these potential actions.
Comments are due Friday, Oct. 17 (11:59pm ET).
Federal Register Details
Comment deadline: Friday, October 17, 2025 (11:59 pm ET)
Submit comments via Regulations.gov – search there for BIS-2025-0258
Direct link to docket and commenting here
Federal Register notice (pdf)
Highlights from Federal Register Notice
Summary
The Secretary of Commerce 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. This investigation has been initiated under section 232 of the Trade Expansion Act of 1962, as amended (Section 232). Interested parties are invited to submit written comments, data, analyses, or other information pertinent to the investigation to the Department of Commerce’s (Department) Bureau of Industry and Security (BIS), Office of Strategic Industries and Economic Security. This notice identifies issues on which the Department is especially interested in obtaining the public’s views
Areas of Focus
The Department is particularly interested in comments and information directed at the criteria listed in § 705.4 of the regulations as they affect national security, including the
following:
(i) The current and projected demand for PPE, medical consumables, and medical equipment, including devices, in the United States;
(ii) the extent to which domestic production of PPE, medical consumables, and medical equipment, including devices, can meet domestic demand;
(iii) the role of foreign supply chains, particularly of major exporters, in meeting United States demand for PPE, medical consumables, and medical equipment, including
devices;
(iv) the concentration of U.S. imports of PPE, medical consumables, and medical equipment, including devices, from a small number of suppliers or foreign nations and the
associated risks;
(v) the impact of foreign government subsidies and predatory trade practices on the competitiveness of PPE, medical consumables, and medical equipment, including devices,
manufacturers, in the United States;
(vi) the economic impact of artificially suppressed prices of PPE, medical consumables, and medical equipment, including devices, due to foreign unfair trade practices and
state-sponsored overproduction;
(vii) the potential for export restrictions by foreign nations, including the ability of foreign nations to weaponize their control over supplies of PPE, medical
consumables, and medical equipment (including devices);
(viii) the feasibility of increasing domestic capacity for PPE, medical consumables, and medical equipment, including devices, to reduce import reliance;
(ix) the impact of current trade policies on domestic production of PPE, medical consumables, and medical
equipment, including devices, and whether additional measures, including tariffs or quotas, are necessary to protect national security;
(x) the potential for foreign control or exploitation of supply chains for PPE, medical consumables, and medical equipment, including devices, supply chain;
(xi) the ability of foreign persons to weaponize the capabilities or attributes of foreign-built PPE, medical consumables, and medical equipment, including devices; and
(xii) any other relevant factors
Definitions
For purposes of this investigation:
- Personal protective equipment (PPE) refers to 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 refers to 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. Pharmaceuticals, such as prescription drugs, over-the-counter drugs, biologics, and specialty drugs, will not be covered under this investigation as those imports are being examined in a separate Section 232 investigation. - Medical equipment refers broadly as 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.
- A medical device is 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.