Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System
fda-device · Food and Drug Administration · Rule · Published 2019-10-29 · Effective 2019-10-29 · 84 FR 57816
Document
Document number
2019-23471
Federal Register citation
84 FR 57816
CFR reference
21 CFR 862
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2019-10-29
Effective date
2019-10-29
HHS docket
Docket No. FDA-2019-N-2484
Abstract
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.