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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 047 Date of Entry 08/21/2017 
FR Recognition Number 13-90
Standard
IEEE  Std 11073-10417-2015
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
Scope/Abstract
Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established by this standard in a manner that enables plug-and play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth glucose meters is defined in this standard.
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
§862.1345 Hexokinase, Glucose Class 2 CFR
§862.1345 Glucose Oxidase, Glucose Class 2 CGA
§862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR
§862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW
N/A Sensor, Glucose, Invasive Class 3 MDS
N/A Automated Insulin Dosing , Threshold Suspend Class 3 OZO
N/A Automated Insulin Dosing Device System, Single Hormonal Control Class 3 OZP
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
  CDRH/OPEQ/OHT7/
  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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