Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit
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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.
- Tags
- health IT, Rule, Health and Human Services Department, Food and Drug Administration
- Related exam domains
- CISM 3: Information Security Program; CISA 1: Information System Auditing Process
- Source record id
- 2026-20725
- First seen by InfoSec Signals
- 10/9/2026
Source: Federal Register API, Office of the Federal Register, National Archives and Records Administration about this source more from it
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