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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 051 Date of Entry 01/14/2019 
FR Recognition Number 13-107
Standard
ISO 11073-20702 First edition 2018-09
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
U.S. Identical Adoption
IEEE Std 11073-20702-2016
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
Scope/Abstract
Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, a communication protocol specification for a distributed system of PoC medical devices and medical IT systems that need to exchange data, or safely control networked PoC medical devices by profiling Web Service specifications, is defined by this standard. Additional Web Service specifications are part of 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.

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
 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
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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