federal_register: 2025-09639

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2025-09639 Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents Rule The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents 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 the Zika virus serological reagents' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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. 2025-05-29 2025 5 https://www.federalregister.gov/documents/2025/05/29/2025-09639/medical-devices-immunology-and-microbiology-devices-classification-of-the-zika-virus-serological https://www.govinfo.gov/content/pkg/FR-2025-05-29/pdf/2025-09639.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents 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...  

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