Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit
Key claim: FDA is placing hematopoietic cell enrichment kits in class II with special controls, so makers can bring them to market through the 510(k) pathway instead of a full premarket approval while still meeting defined safety requirements.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
FDA continues its pattern of placing novel diagnostic and therapeutic devices into Class II with special controls rather than requiring the costlier Class III premarket approval. For hematopoietic cell enrichment kits — used to isolate blood-forming cells for research and clinical processing — this gives manufacturers a 510(k) route to market while still imposing defined performance and labeling controls.