The FDA appears to be classifying blood irradiators as medical devices. This regulatory action would likely establish premarket approval requirements and safety standards for the devices.
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Filing of Color Additive Petition: International Association of Color Manufacturers; Request to Amend the Color Additive Regulations to Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests