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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 064 Date of Entry 01/27/2015 
FR Recognition Number 13-72
Standard
IEEE  Std 11073-10425-2014
Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
Identical Adoption
ISO IEEE 11073-10425 First edition 2016-06-15
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
Scope/Abstract
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.
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.
Transition Period
FDA recognition of IEEE Std 11073-10425-2014 [Rec# 13-72] will be superseded by recognition of IEEE Std 11073-10425-2023 [Rec# 13-144]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-72] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 13-72] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Sensor, Glucose, Invasive Class 3 MDS
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
 Jessica Flynn
  FDA/OC/CDRH/OPEQ/OHTVII/DCTD/DB/
  240-402-9099
  Jessica.flynn@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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