FEDERAL REGISTER · PROPOSED RULEMarch 18, 2026PROPOSED — NOT IN FORCE

Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis

What this record is not

Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSPROPOSED — NOT IN FORCE

PROPOSED EFFECTIVE—

COMMENTS CLOSEMay 18, 2026 · closed

APPLIES TO · SPEQ TAGBiologicsDevice

Document type

Proposed Rule

Agency

Health and Human Services Department

Published

March 18, 2026

Comments close

May 18, 2026

Document number

2026-05322

CFR references

21 CFR 892

Docket

FDA-2025-N-5995

ABSTRACT

The Food and Drug Administration (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. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from use of the devices.

Abstract as published in the Federal Register.

AMENDING THE SAME CFR PART · 21 CFR 892

2026-09-17Final ruleMedical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
2026-09-10Final ruleMedical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
2026-08-10Proposed ruleRadiology Devices; Reclassification of Digital Breast Tomosynthesis System
2026-08-06Final ruleMedical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
2026-07-29Final ruleMedical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
2026-06-17Final ruleMedical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan

21 CFR 892 in the tracker's recent documents →

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