Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System
Information
Type
Rule
Regulated products
Medical Devices
Published
October 29, 2019
Last updated
October 29, 2019
Description
Document number 2019-23471. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)