FDA Splits Blood Irradiators into Approval Tiers
Published Date: 3/18/2026
Proposed Rule
Summary
The FDA is proposing new rules to make blood irradiators safer and more reliable. Devices that stop a serious transfusion problem will need a simpler review, while those aimed at preventing cancer spread will face a tougher approval process. If you make or use these devices, get ready to comment by May 18, 2026, and expect some extra costs for the stricter reviews.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 2 costs, 1 mixed.
Metastasis Irradiators Require PMA
If you make blood irradiators intended to irradiate intraoperatively salvaged blood to prevent metastasis, the FDA proposes to classify those devices as Class III and to require filing a premarket approval (PMA) application. FDA is also issuing a proposed order requiring PMA filing for these devices, which means manufacturers must submit PMAs to seek marketing authorization.
TA-GVHD Irradiators Moved to Class II
If you make blood irradiators intended to prevent transfusion-associated graft-versus-host disease (TA-GVHD), the FDA proposes to classify those devices as Class II (special controls) and require premarket notification (510(k)). The rule would establish special controls (performance testing, labeling, and quality controls) that manufacturers must meet before marketing these prescription devices.
Option to Use Predetermined Change Plans
Manufacturers may use Predetermined Change Control Plans (PCCPs) to implement future device modifications without submitting a new 510(k) or PMA supplement if the changes are consistent with an FDA-approved or cleared PCCP. The proposal references section 515C of the FD&C Act (added by FDORA) as the legal basis for PCCPs.
Estimated Industry Costs and Benefits
FDA estimates that annualized benefits over 10 years would range from $84 to $180,268 at a 7% discount rate (primary estimate $90,176), and from $86 to $184,271 at a 3% discount rate (primary estimate $92,178). Annualized costs are estimated to range from $0.68 million to $1.51 million at 7% (primary estimate $1.07 million) and from $0.66 million to $1.53 million at 3% (primary estimate $1.07 million). The rule also identifies one-time industry costs to read the rule and revise labeling.
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Key Dates
Department and Agencies
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