FDA Targets Blood-Zapping Devices in Cancer Fight
Published Date: 3/18/2026
Proposed Rule
Summary
The FDA is planning to require companies that make blood irradiators used during cancer surgeries to get special approval before selling them. This change helps make sure these devices are safe and effective in preventing cancer spread. If finalized, manufacturers will have about 30 months to submit their approval applications, so they should get ready soon!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 3 costs, 1 mixed.
PMA requirement for blood irradiators
If finalized, manufacturers of blood irradiators used to irradiate intraoperatively salvaged blood to help prevent metastasis must file a premarket approval (PMA). The PMA must be filed by the last day of the 30th calendar month after the device is classified into class III.
Market removal and investigational use rules
If a PMA is not timely filed, the device could be deemed adulterated and subject to enforcement, and manufacturers must stop distribution if a PMA is denied. Devices may only be distributed for investigational use under an approved investigational device exemption (IDE).
PMA must include clinical evidence and testing
FDA requires a PMA to include valid scientific evidence, full preclinical and clinical reports, and performance testing showing reasonable assurance of safety and effectiveness. FDA also encourages early meetings via the Q-Submission Program and recommends submitting an IDE at least 30 days before the PMA filing date to avoid interrupting investigations.
Short review window, continued marketing if timely filed
FDA says it intends to review any PMA for these devices within 180 days. A device that was in commercial distribution before May 28, 1976 (or found substantially equivalent by that date) may remain on the market during FDA's PMA review if a PMA is filed on time.
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Key Dates
Department and Agencies
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