G/TBT/N/USA/2268

31 March 2026

(26-2549)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: UNITED STATES OF AMERICA

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

Department of Health and Human Services (HHS), Food and Drug Administration (FDA) [2301]

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Blood irradiator devices; Quality (ICS code(s): 03.120); Radiographic equipment (ICS code(s): 11.040.50)

5.

Details of notified document(s) (title, number of pages and languages, means of access): Medical Devices; Radiology Devices; Classification of Blood Irradiators; (16 page(s), in English)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/USA/26_01779_00_e.pdf

6.

Description of content: Proposed rule - The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; Quality requirements

8.

Relevant documents:

91 Federal Register (FR) 12951, 18 March 2026; Title 21 Code of Federal Regulations (CFR) Part 892:

https://www.govinfo.gov/content/pkg/FR-2026-03-18/html/2026-05320.htm

https://www.govinfo.gov/content/pkg/FR-2026-03-18/pdf/2026-05320.pdf

This proposed rule is identified by Docket Number FDA-2025-N-5996. The Docket Folder is available from Regulations.gov at https://www.regulations.gov/docket/FDA-2025-N-5996/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.

Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis; Proposed amendment; proposed order, published 18 March 2026:

https://www.govinfo.gov/content/pkg/FR-2026-03-18/html/2026-05322.htm

https://www.govinfo.gov/content/pkg/FR-2026-03-18/pdf/2026-05322.pdf

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 18 May 2026

[ ] 60 days from notification

WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point by or before 4pm Eastern Time on 18 May 2026. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with the FDA and will also be submitted to the Docket on Regulations.gov if received within the comment period.

Contact details of agency or authority designated to handle comments regarding the notification:

Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov