Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

065

Date of Entry 12/22/2025

FR Recognition Number

13-156

Standard

IEEE Std 11073-10471-2023
Health Informatics - Device interoperability - Part 10471: Personal health device communication - Device specialization - Independent living activity hub

Identical Adoption

ISO IEEE 11073-10471 Second Edition 2024-09
Health Informatics - Device Interoperability - Part 10471: Personal Health Device Communication - Device Specialization-Independent Living Activity Hub

Scope/Abstract

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth independent living activity hub devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability is established in this standard. Appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. 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 independent living activity hubs 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.

Relevant FDA Guidance and/or Supportive Publications*

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.

Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued August 2023.

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.

Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.

Multiple Function Device Products: Policy and Considerations - Guidance for Industry and Food and Drug Administration, issued July 2020.

Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued 2023.

Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.

Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.

General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019.

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 Contacts

Maria Isabel Tejero Del Rio

FDA/OC/CDRH/OPEQ/OHTIII/

301-796-5322

Isabel.Tejero@fda.hhs.gov

Loriano Galeotti

FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/

301-796-5279

Loriano.Galeotti@fda.hhs.gov

Standards Development Organization

IEEE

Institute of Electrical and Electronic Engineers