Orthofix International NV披露，美国食品药品监督管理局（FDA）已将其非侵入性骨生长刺激器产品类别，从原先的监管分类重新划定为II类医疗器械。此次监管层级的调整，标志着该产品线在上市前审查与合规要求方面将面临新的规范框架。
Orthofix International NV披露，美国食品药品监督管理局（FDA）已将其非侵入性骨生长刺激器产品类别，从原先的监管分类重新划定为II类医疗器械。此次监管层级的调整，标志着该产品线在上市前审查与合规要求方面将面临新的规范框架。
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