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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 7-307
CLSI  POCT05 2nd Edition
Performance Metrics for Continuous Interstitial Glucose Monitoring
This guideline provides recommendations for methods used to determine analytical and clinical metrics of continuous glucose monitoring (CGM) as an indicator of blood glucose values. It discusses use cases, point accuracy, trend accuracy, evaluation of threshold alerts, system stability and reliability, clinical studies for assessing CGM performance, calibration, traceability of measurement, cybersecurity, and device labeling.

The intended users of this guideline are in vitro diagnostic and medical device manufacturers, regulatory agencies, and health care professionals. This guideline is not intended for use by patients and does not discuss devices that do not meet the definitions of continuous, interstitial, and glucose monitoring.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1355 Integrated Continuous Glucose Monitoring System, Factory Calibrated Class 2 QBJ
§862.1355 Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management Class 2 QDK
§862.1355 Integrated Continuous Glucose Monitoring System For Professional Retrospective Use Class 2 QDL
§862.1355 Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Class 2 QLG
N/A Sensor, Glucose, Invasive Class 3 MDS
N/A Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor Class 3 OYC
N/A Automated Insulin Dosing , Threshold Suspend Class 3 OZO
N/A Automated Insulin Dosing Device System, Single Hormonal Control Class 3 OZP
N/A Continuous Glucose Monitor, Implanted, Adjunctive Use Class 3 QCD
N/A Sensor, Glucose, Implanted, Non-Adjunctive Use Class 3 QHJ
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ghazaleh Esmaili
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.