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# Device Premarket Imaging Guidance
- URL: https://www.fdaweb.com/device-premarket-imaging-guidance/
- Published: 2019-04-18T12:00:00.000Z
- Updated: 2026-09-15T01:21:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143900

FDA has published a draft guidance, *Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions*, that, when finalized, will provide detailed recommendations for manufacturers on the information that should be included in PMA, HDE, and 510(k) submissions, IDE applications, and de novo requests for medical devices that include quantitative imaging functions. In general, the [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM636178.pdf?ref=fdaweb.com) says, manufacturers preparing premarket submissions for devices that include quantitative imaging functions should provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate that the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand, and interpret the values provided by the quantitative imaging function.

The guidance applies to all devices that generate quantitative imaging values across a wide range of imaging modalities, intended uses, levels of automation, and complexity of algorithms.