U.S. FEDRegulation
FDA classifies hematopoietic cell enrichment kit as class II device
The Food and Drug Administration classified the hematopoietic cell enrichment kit into class II with special controls. The agency determined the classification provides reasonable assurance of the device's safety and effectiveness and said it should expand patient access to innovative devices by reducing regulatory burden. The order took effect October 9, 2026.
Key points
- Hematopoietic cell enrichment kit classified into class II (special controls).Federal Register
- Special controls identified in the order form the codified classification language.Federal Register
- FDA says classification gives reasonable assurance of safety and effectiveness.Federal Register
- Agency expects reduced regulatory burden and wider patient access.Federal Register
- Order effective October 9, 2026; the classification has applied since November 6, 2023. Published as 91 FR 64609.Federal Register
- Amends 21 CFR part 866 (FR Doc. 2026-20725).Federal Register
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RegulationU.S.FDA Class II Classification: Hematopoietic Cell Enrichment Kit (2026)HealthcareFor practitionersFor governance