federal_register: 2019-23471

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2019-23471 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System Rule The Food and Drug Administration (FDA or we) is classifying the continuous glucose monitor data management system into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general 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. 2019-10-29 2019 10 https://www.federalregister.gov/documents/2019/10/29/2019-23471/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-continuous https://www.govinfo.gov/content/pkg/FR-2019-10-29/pdf/2019-23471.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or we) is classifying the continuous glucose monitor data management system into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general...

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