federal_register: 2021-26200

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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
2021-26200 Medical Devices; Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System Rule The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization system 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 esophageal tissue characterization system's 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. 2021-12-02 2021 12 https://www.federalregister.gov/documents/2021/12/02/2021-26200/medical-devices-gastroenterology-urology-devices-classification-of-the-esophageal-tissue https://www.govinfo.gov/content/pkg/FR-2021-12-02/pdf/2021-26200.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization system 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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