Advisors and FDA agree: Reclassify blood irradiators for malignancy prevention to high-risk

This week, a panel of the FDA’s Medical Devices Advisory Committee (MDAC) discussed the FDA proposal to reclassify blood irradiators, when used intraoperatively to prevent malignancy, into device Class III – high risk. Though the technology and application are decades old, the devices are understudied for this purpose, leading panel members to request a high bar for evidence to support safety and effectiveness.

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