Publication of the List of Medical Devices Requiring Specific Authorization for the North Korea Sanctions Regulations
Rule published June 11, 2026 · 91 FR 35400
- Document number
- FR Doc. 2026-11761
- Type
- Rule
- Published
- June 11, 2026
- Citation
- 91 FR 35400 (page 35,400)
- Action
- List of medical devices excluded from North Korea Sanctions Regulations general license.
- Effective
- June 11, 2026
- Dates
- This list is effective June 11, 2026.
- Official sources
- PDF (govinfo.gov) · federalregister.gov
Summary
The Federal Register's summaryThe Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing a list of medical devices that may not be exported or reexported to North Korea pursuant to the general license authorizing the exportation or reexportation to North Korea of certain agricultural commodities, medicine, medical devices, and replacement parts and components. The exportation or re-exportation of these excluded medical devices to North Korea requires specific authorization from OFAC.
Regulations cited
- 31 CFR part 510 (today: North Korea Sanctions Regulations) · Other documents citing it · eCFR as of June 11, 2026
OFAC has reused some part numbers, so today's heading can name a different regulation from the one this document concerned.
Text
As the Government Publishing Office publishes it. Pages OFAC printed as images (in recent notices, the lists of names) are in the official PDF.
[Federal Register Volume 91, Number 112 (Thursday, June 11, 2026)]
[Rules and Regulations]
[Page 35400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-11761]
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DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 510
Publication of the List of Medical Devices Requiring Specific
Authorization for the North Korea Sanctions Regulations
AGENCY: Office of Foreign Assets Control, Treasury.
ACTION: List of medical devices excluded from North Korea Sanctions
Regulations general license.
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SUMMARY: The Department of the Treasury's Office of Foreign Assets
Control (OFAC) is publishing a list of medical devices that may not be
exported or reexported to North Korea pursuant to the general license
authorizing the exportation or reexportation to North Korea of certain
agricultural commodities, medicine, medical devices, and replacement
parts and components. The exportation or re-exportation of these
excluded medical devices to North Korea requires specific authorization
from OFAC.
DATES: This list is effective June 11, 2026.
FOR FURTHER INFORMATION CONTACT: OFAC: Assistant Director for
Regulatory Affairs, 202-622-4855; or https://ofac.treasury.gov/contact-
ofac.
SUPPLEMENTARY INFORMATION:
Electronic Availability
This document and additional information concerning OFAC is
available on OFAC's website (https://ofac.treasury.gov).
Background
On February 16, 2024, OFAC adopted a final rule (89 FR 12233)
amending the North Korea Sanctions Regulations, 31 CFR part 510 (the
``Regulations''), to, among other things, add a new general license at
Sec. 510.521 authorizing the exportation or reexportation to North
Korea of certain agricultural commodities, medicine, medical devices,
and replacement parts and components that are not subject to the Export
Administration Regulations, 15 CFR parts 730 through 774. Section
510.521(b)(3) defines a medical device to mean an item that (i) falls
within the definition of ``device'' in section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321), and (ii) is not on the List of
Medical Devices Requiring Specific Authorization (the ``List''), as
maintained on OFAC's website (https://ofac.treasury.gov) on the North
Korea Sanctions page. OFAC is now publishing the List in the Federal
Register and on its website.
The text of the List is provided below.
List of Medical Devices Requiring Specific Authorization (June 11,
2026)
The list below comprises the List of Medical Devices Requiring
Specific Authorization as identified in 31 CFR 510.521(b)(3)(ii).
General Medical Supplies and Equipment
Oxygen Generators
Pumps with flow rates of more than 1 liter/minute
Diagnostic Medical Imaging Equipment:
[cir] Gamma imaging equipment
[cir] Tactile Imaging equipment
[cir] Thermography equipment
Laboratory
Freeze-drying (lypophilizers) and spray-drying equipment
Fermenters, bioreactors, and chemostats
Crossflow (tangential) filtration systems and disposable
filter cartridges
Biocontainment chambers and hoods, including isolators,
biological safety cabinets, and laminar flow hoods
Aerosol inhalation equipment, including full-body, head-only,
nose-only, and mask exposure systems
Decontamination showers
Laboratory glassware made from borosilicate glass, including
reaction vessels, storage tanks, heat exchangers, and distillation and
absorption columns
Autoclaves larger than 20 liters
Clinical laboratory water baths larger than 10 liters
Laboratory hot plates exceeding 1 square foot of heating
surface
Freezers capable of reaching temperatures of -80 degrees
Celsius
Laboratory shakers and incubator shakers
Carbon dioxide incubators
Circular dichroism spectrometers
Spectrometers and spectrophotometers not designed for clinical
use
Fluorometers
Nuclear Magnetic Resonance Spectrometers
Polymerase Chain Reaction (PCR) machines
Differential Scanning Calorimeters
Chromatography Equipment
Fluorescence Microscopes
Confocal Microscopes
Cascade Impactors
Dynamic Light Scattering Equipment
Quasielectric Light Scattering Equipment
Full face mask respirators, including Powered Air Purifying
Respirators (PAPR)
Decontamination systems using the following chemicals:
[cir] Vaporized hydrogen peroxide
[cir] Vaporized paraformaldehyde
[cir] Vaporized ethylene oxide
[cir] Isopropanol (99% purity)
High Efficiency Particulate Air (HEPA) Filtration Systems and
HEPA filters
Fourier Transformation Infrared (FTIR) Systems
Balancing machines
Motion simulators
Rate tables
Fluorescence-activated cell sorters (FACS)
Bradley T. Smith,
Director, Office of Foreign Assets Control.
[FR Doc. 2026-11761 Filed 6-10-26; 8:45 am]
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