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

What it does

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.

The Food and Drug Administration's summary, as published in the Federal Register.

What it would change

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 892

What happens next and when

Either electronic or written comments on the proposed order must be submitted by May 18, 2026. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to market blood irradiators intended for use in the irradiation of intraoperatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis must submit a PMA prior to the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective. See section III for the effective date of any final order that may publish based on this proposed order. See section VI of this document for more information about submitting a PMA.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2025-N-5995 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register