REGULATORY UPDATE: FDA Proposes New Classification Rule for Blood Irradiators Used to Prevent TA-GVHD

The Food and Drug Administration issued a proposed rule today to formally classify blood irradiator devices used to irradiate blood and blood components to prevent transfusion-associated graft-versus-host disease (TA-GVHD) as Class II medical devices subject to special controls and premarket notification (510[k]) requirements. Blood irradiators are currently unclassified preamendment devices that FDA regulates through the 510(k) pathway.

The agency’s proposal aligns with recommendations from the Radiological Devices Advisory Panel, which concluded that general controls alone are insufficient to ensure the safety and effectiveness of these devices. However, the panel concluded that the risks can be adequately mitigated through the use of special controls. FDA considers devices to prevent TA-GVHD to be moderate-risk and appropriate for Class II classification because their intended use is well established in clinical practice and risks can be mitigated through special controls, such as:

• Performance testing to demonstrate that the device can deliver 25 Gy of radiation to the central portion of the container and at least 15 Gy to all other points, consistent with longstanding FDA recommendations for irradiated blood products.
• Software verification and validation and electrical and electromagnetic safety testing.
• Labeling requirements to describe device specifications, dosimetry, maintenance procedures, safe loading configurations and postmarketing surveillance.
• Warnings about potential effects of irradiation on blood components, including reduced shelf life and elevated potassium levels in irradiated red blood cell units.
• Software-related controls, electrical safety testing, electromagnetic compatibility, information of radiation source decay and dosimetric distribution information.

The proposed rule also addresses the irradiation of intraoperatively salvaged blood in patients with cancer to prevent metastasis. For that use, FDA proposes classification as a Class III device requiring premarket approval, stating that the agency “believes that insufficient information exists to determine that general controls and special controls would provide reasonable assurance of safety and effectiveness for blood irradiators intended to prevent metastasis, and that these devices present a potential unreasonable risk of illness or injury.”

FDA said the proposed rule would clarify regulatory expectations for manufacturers and help ensure consistent performance standards for blood irradiator devices widely used in transfusion practice. The agency also noted that many of the proposed special controls reflect practices already used by manufacturers of currently cleared devices.

Regarding implementation, FDA said new or significantly modified blood irradiators would be required to meet the special controls and obtain 510(k) clearance before marketing once the rule takes effect, while currently marketed devices would generally have 12 months after the effective date of a final rule to comply. Manufacturers of devices intended to prevent metastasis would have 30 months to submit premarket approval applications if the classification is finalized.

The agency is accepting comments on the proposed rule until May 18.