This regulation appears to establish a premarket approval process for blood irradiation devices intended to prevent metastasis. The rule would affect medical device manufacturers and clinical applications.
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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