Guides for working with device data

Each guide explains one regulation or metric and the device data it depends on, including the fields a reading needs and how they are coded and stored. They are written for device makers, trial sponsors, researchers and hospital teams.

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Fig. 1. The guides on a shelf, with a recording strip as a bookmark.

Regulation and evidence

  1. Post-market surveillance

    for device makers

    What section 522 of the FD&C Act lets FDA order, what the EU Medical Device Regulation asks for, and the device data each obligation draws on.

  2. PMCF device data

    for device makers

    Post-market clinical follow-up (PMCF) under the EU Medical Device Regulation, and how readings from routine care can feed a PMCF plan.

  3. FDA DHT guidance

    for trial sponsors

    What FDA's December 2023 guidance on remote data acquisition asks of trial data, mapped to the fields on a reading.

Metrics and the chart

  1. CGM metrics

    for researchers and sponsors

    Time in range, glycemic variability and the ambulatory glucose profile (AGP), computed from coded continuous glucose monitor (CGM) readings.

  2. Epic flowsheets

    for hospitals

    How a device reading maps to a row in an Epic flowsheet, and the review step before it files.

Contact us about a guide's data requirements

In the demo, we code and file readings from your own devices with the fields these guides describe. We reply within one business day with times to talk.

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