この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2026/3/181 分で読めます
Medical Devices; Radiology Devices; Classification of Blood Irradiators
ローカル自動翻訳 · 情報源の原言語
概要
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.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →