Medical Devices; Radiology Devices; Classification of Blood Irradiators
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- Title
- Medical Devices; Radiology Devices; Classification of Blood Irradiators
- Posted
- Mar 18, 2026
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- May 18, 2026Comment from Notification and Comment Center on Technical Barriers to Trade for the State Administration for Market Regulation, ChinaOpposeGovernment📎 Attachment
The government of the People's Republic of China opposes the proposed classification of blood irradiators, arguing that the FDA's "intended use" logic creates unnecessary trade barriers and deviates from international standards. They request a unified regulatory classification based on inherent hazards, mutual recognition of international testing data, and reduced compliance costs for small and medium-sized enterprises.
Read comment → - May 6, 2026Mariah MorgadoSupportIndividual📎 Attachment
Mariah Morgado, a law student, supports the proposed rule to classify blood irradiators to improve patient safety. However, she recommends clarifying the device definition, expanding the cost-benefit analysis to include health and indirect economic impacts, and extending the compliance timeline for geographically isolated areas like Hawai’i.
Read comment → - May 5, 2026Angela PerezSupportIndividual
The commenter supports the FDA's proposed rule to reclassify blood irradiator devices based on their specific clinical uses and risk levels. They specifically agree with placing metastasis-reducing devices in Class III and maintaining Class II for TA-GVHD prevention devices with special controls.
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