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Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register 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.
- Document type
- Proposed Rule
- Federal Register document number
- 2026-05322
- Published
- Mar 18, 2026
- Action
- Proposed amendment; proposed order.
- Docket
- FDA-2025-N-5995
- Comments posted on Regulations.gov (at last check)
- 2
- CFR parts
- 21 CFR 892
- DATES section (from the document)
- 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.
- Topics (auto-tagged)
- Vaccines / biologics Medical devices
Source: Federal Register API, document 2026-05322. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.