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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 13-91
Standard
ISO IEEE  11073-10419 First edition 2016-06-15
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
Scope/Abstract
This standard establishes a normative definition of communication between personal telehealth insulin pump 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/IEEE11073 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 functionality of personal telehealth insulin pump devices. In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5725 Pump, Infusion, Insulin Class 2 LZG
§880.5725 Pump, Infusion, Insulin Bolus Class 2 OPP
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
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems issued November 9, 2012.

Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps issued March 1, 1993.

Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff issued December 2, 2014.

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
 Joshua Balsam
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/DB/
  240-402-6521
  joshua.balsam@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
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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