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url: https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation
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canonical_url: https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation
source: us-federal-register
category: government/us
category_raw: Rule
country: us
region: us
tags:
- Medical devices
- Radiation protection
- X-rays
lang: en
published_at: '2026-07-29T00:00:00Z'
fetched_at: '2026-07-29T09:01:27.610624Z'
updated_at: '2026-07-29T09:06:43Z'
status: published
content_hash: df0b8b31fa9dd631fb8e42f78ac04f07b1bcdd1a2d77ed417461ea9d367d9e96
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license_note: full
license_basis: public-domain-17usc105
body_available: false
attribution: 'Source: Office of the Federal Register, National Archives and Records
  Administration'
license_rule: source:us-federal-register
summary: The Food and Drug Administration (FDA) is classifying the phase-changing
  fiducial marker for radiation therapy into class II (special controls). The special
  controls that apply to the device type are identified in this order and will be
  part of the codified language for classification of the phase-changing fiducial
  marker for radiation therapy. We are taking this action because we have determined
  that classifying the device into class II will provide a reasonable assurance of
  safety and effectiveness of the device. We believe this action will also enhance
  patients' access to beneficial innovative devices, in part by reducing regulatory
  burdens.
summary_source: official
summary_en: The Food and Drug Administration (FDA) is classifying the phase-changing
  fiducial marker for radiation therapy into class II (special controls). The special
  controls that apply to the device type are identified in this order and will be
  part of the codified language for classification of the phase-changing fiducial
  marker for radiation therapy. We are taking this action because we have determined
  that classifying the device into class II will provide a reasonable assurance of
  safety and effectiveness of the device. We believe this action will also enhance
  patients' access to beneficial innovative devices, in part by reducing regulatory
  burdens.
provenance:
  doc_id: 2026-15303
  doc_id_scheme: fr_docnum
  issuer:
  - Health and Human Services Department
  - Food and Drug Administration
  doc_type: Rule
  subtype: null
  action: Final amendment; final order.
  significant: null
entities:
- name: Cognitive Bias, AI Scaling Rule
  type: UNKNOWN
- name: Medical Diagnosis
  type: event
key_facts: []
related: []
related_auto:
- name: Research Area
  type: UNKNOWN
  weight: 1.0
- name: Gemini
  type: artifact
  weight: 1.0
- name: AIツール
  type: method
  weight: 1.0
- name: Claude
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title: Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial
  Marker for Radiation Therapy
---

# Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy

## TL;DR
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the phase-changing fiducial marker for radiation therapy. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Key Points
- Medical devices / Radiation protection / X-rays

## Details
(本文なし。リンク先参照)

## Source
元記事: [Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy](https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation) — published 2026-07-29T00:00:00Z