Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators In
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
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Proposed Rule |
| Published | 2026-03-18 |
| Summary | 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 number | 2026-05322 |
| Official record | https://www.federalregister.gov/documents/2026/03/18/2026-05322/effective-date-of-requirement-for-premarket-approval-applications-for-blood-irradiators-intended-to |