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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 13-114
Standard
IEEE Std 11073-10101-2019
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
Scope/Abstract
This standard defines a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object-oriented information model that is for medical device communication.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard provides updated and new nomenclature elements which support semantic data exchange between medical devices and other entities, and therefore supports improved safety, effectiveness and secure interoperability.
This standard is relevant to all medical devices which claim interoperability with other networked entities and is being recognized on its scientific and technical merit because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Relevant guidance:

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

2. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 2005.

3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff: issued September 2019

4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019.

5. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff , issued October 2014

6. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005

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


FDA Technical Contacts
 Konstantinos Makrodimitris
  FDA/CDRH/OSPTI/DAHRSSP
  301-796-6946
  konstantinos.makrodimitris@fda.hhs.gov
 Sajjad Syed
  FDA/OC/CDRH/OPEQ/ORP/
  301-796-6295
  sajjad.syed@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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