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描述医疗器械儿童标签中的不一致性

Grzegorz Zapotoczny1,2, Alexis Snitman3, Payal Shah4

  • 1Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.

JAMA network open
|December 4, 2025
PubMed
概括

美国食品和药物管理局 (FDA) 批准的大多数高风险医疗器械缺乏特定的儿科年龄标签,导致安全和监测问题. 美国食品和药物管理局应实施强制性儿科设备标签要求.

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