Regulation Brief October 9, 2026, 2:03 AM ET

FDA classifies hematopoietic cell enrichment kit as class II device

The order designates the kit as a class II device with special controls. The special controls will be part of the codified language for classification of the hematopoietic cell enrichment kit.

Primary source

Federal Register rule, October 9, 2026

Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit

Read the source: Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit federalregister.gov

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