Data / Federal rules / 2026-05322
Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
The Food and Drug Administration published this proposed rule in the Federal Register on March 18, 2026. Comments closed on May 18, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-05322
- Type
- Proposed rule
- Action
- Proposed amendment; proposed order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 18, 2026
- Comments due
- May 18, 2026
- Dates
- 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
- Docket
- Docket No. FDA-2025-N-5995
- Code of Federal Regulations
- 21 CFR 892
- Topics
- Medical devices; Radiation protection; X-rays
- Pages
- 7
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Rules on radiation protection · Rules on x-rays · Published in March 2026
Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.