{
  "platform": "civiq",
  "version": 1,
  "type": "comment-period",
  "data": {
    "documentNumber": "2026-05320",
    "title": "Medical Devices; Radiology Devices; Classification of Blood Irradiators",
    "summary": "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.",
    "agency": "Health and Human Services Department",
    "commentUrl": "http://www.regulations.gov/commenton/FDA-2025-N-5996-0001",
    "commentsCloseOn": "2026-05-18",
    "daysUntilClose": 60,
    "url": "https://www.federalregister.gov/documents/2026/03/18/2026-05320/medical-devices-radiology-devices-classification-of-blood-irradiators"
  },
  "source": {
    "url": "https://www.federalregister.gov/documents/2026/03/18/2026-05320/medical-devices-radiology-devices-classification-of-blood-irradiators",
    "api": "federalregister.gov"
  }
}