Home / Agencies / HHS / 2026-05322
Proposed Rule

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

Agency
HHS
Document Number
2026-05322
Published
March 18, 2026
Effective Date
-

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.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

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Frequently Asked Questions

What is the 2026-05322 Federal Register document?
Document 2026-05322 is a Proposed Rule published by the Department of Health and Human Services in the Federal Register on March 18, 2026. 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. View the original at https://www.federalregister.gov/documents/2026/03/18/2026-05322/effective-date-of-requirement-for-premarket-approval-applications-for-blood-irradiators-intended-to.
Is document 2026-05322 an economically significant rule?
No. Document 2026-05322 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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