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    Health Law Daily Wrap Up, MEDICAL DEVICES—PROPOSED RULES: FDA proposes filing requirement for blood irradiator PMAs, (Mar 23, 2026)

    By WK Editorial Staff

    To present reasonable assurance of safety and effectiveness of blood irradiators intended to prevent metastasis, the FDA tentatively concludes that manufacturers should submit performance testing, including clinical studies of their product, to suppo ...

    By WK Editorial Staff

    To present reasonable assurance of safety and effectiveness of blood irradiators intended to prevent metastasis, the FDA tentatively concludes that manufacturers should submit performance testing, including clinical studies of their product, to support PMA approval.

    The FDA is proposing to require the filing of a premarket approval application (PMA) for blood irradiators intended to irradiate intraoperatively salvaged blood for cancer patients undergoing surgery to assist in prevention of metastasis, which are unclassified, preamendments devices. Blood irradiators intended to prevent metastasis are used to irradiate intraoperatively salvaged blood ex vivo from cancer patients undergoing surgery to assist in the prevention of metastasis. In accordance with sections 501(f)(2)(B) and 515(b) of the Food, Drug, and Cosmetic Act (FDC Act), the FDA is proposing to require that a PMA be filed with the agency for blood irradiators intended to prevent metastasis by the last day of the 30th calendar month beginning after the month in which the classification of the device in class III becomes effective (Proposed Rule, 91 Fed. Reg. 12966, March 18, 2026).

    Dates. Either electronic or written comments on the proposed order must be submitted by May 18, 2026.

    FederalRegisterIssuances: ProposedRules FDCActNews MDeviceNews SafetyNews

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