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

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Proposed Rule62 days to comment

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

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.

Published

Mar 18, 2026

Comments Close

May 18, 2026(62d)

Citation

91 FR 12966

Agencies

2026-05322Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis

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Public Comment Period Open

62 days remaining — closes May 18, 2026.

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Agencies (2)

FDA — Food and Drug Administration

HHS — Health and Human Services Department

Topics

Medical devices Radiation protection X-rays

Docket IDs

Docket No. FDA-2025-N-5995

CFR References

21 CFR 892

Document Details

Type: Proposed Rule
Action: Proposed amendment; proposed order.
Document #: 2026-05322
Citation: 91 FR 12966
Publication Date: Mar 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 publish based on this proposed order. See section VI of this document for more information about submitting a PMA.
Federal Register Pages: Vol. 91, pp. 12966–12972
Page Views: 2

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