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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 066 Date of Entry 05/25/2026 
FR Recognition Number 13-158
Standard
IEEE  1752.1-2021
Open Mobile Health Data: Representation of Metadata, Sleep, and Physical Activity Measures
Scope/Abstract
This standard defines specifications for the representation of mobile health minimum metadata, data related to sleep and physical activity. Data pertaining some environmental variables, surveys, and relevant units of measure and value sets are defined because they are needed for the representation of minimum metadata, data related to sleep and physical activity. The standard is agnostic with respect to current or future devices or apps that measure those types of health data.
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*
1. Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
2. Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued 2023
3. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
4. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued August 2023.
5. 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.
6. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued February 2026.
7. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
8. General Principles of Software Validation - Guidance for Industry and FDA Staff, issued January 2002.

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
 Shawn Forrest
  FDA/OC/CDRH/OSPTI/DHCE/DDHTA/
  301-796-5554
  shawn.forrest@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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