| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
054
|
Date of Entry 07/06/2020
|
|
FR Recognition Number
|
13-113
|
| Standard | |
IEEE Std 11073-20601-2019
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
|
Scope/Abstract| Within the context of the ISO/IEEE 11073 personal health device standard family, this standard defines an optimized exchange protocol and modeling techniques to be used by implementers of personal health devices to create interoperability between device types and vendors. This standard establishes a common framework for an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible. |
|
| Extent of Recognition
|
Rationale for Recognition
This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices, like weigh-scales, fitness trackers, activity monitors, treadmills, etc., and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes). Interoperability between these types of devices is key to communicating this data to interested parties including healthcare providers, custodians, and family members, enabling people to be better-informed participants in the management of their health.
This standard is relevant to all medical devices and personal health products which claim interoperability with other networked entities and is being recognized on its scientific and technical merit because it supports existing regulatory policies. |
|
Transition Period
| FDA recognition of IEEE Std 11073-20601-2019 [Rec# 13-113] will be superseded by recognition of ISO IEEE 11073-20601 Third Edition 2022-12 [Rec# 13-136]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-113] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 13-113] will not be accepted. |
|
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
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
