• US FDA recommends inclusion of performance specifications and related data for premarket submissions of devices with quantitative imaging functions;
  • Recommendations cover 510(k), PMA and other types of medical device premarket applications;
  • Applicants whose devices include quantitative imaging components should include functional descriptions, technical performance assessments and labeling information in FDA submissions.

US medical device market applicants whose devices include quantitative imaging features should include performance specifications for these features in their premarket submissions, according to new guidance from the Food and Drug Administration.

The FDA draft guidance lays out recommendations for 510(k) premarket notification, Premarket Approval (PMA), de novo and other applicants in terms of performance specifications as well as data to show that devices’ quantitative imaging functions meet those specifications. The guidance focuses on device information, technical performance assessment and user information to include in premarket submissions

What to include in FDA premarket submissions

FDA identifies three broad types of information to include in 510(k) and other premarket applications for devices with quantitative imaging functions:

  • Function description: A technical description of all quantitative imaging components of a device; level of description detail should be commensurate to level of complexity of the quantitative imaging function.
  • Technical performance assessment: Performance specifications related to claims and uncertainties regarding quantitative imaging components included in a device’s labeling; intended use of a device’s quantitative imaging function should determine pertinent performance specifications to identify.
  • Labeling and user instructions: Labeling should meet all relevant FDA requirements including 21 CFR Part 801 and also enable end users to understand and interpret data generated by the device’s quantitative imaging function.

The guidance also provides examples of performance specifications to include in premarket submissions for devices with manual, semi-automated and fully automated quantitative imaging functionalities.

Additional US FDA medical device regulatory resources from Emergo by UL:

  • FDA submission consulting for medical device and IVD companies
  • FDA medical device classification consulting
  • Medical device performance testing
  • Whitepaper: Preparing a US FDA 510(k) submission
  • Whitepaper: Medical device labeling, standards and symbols


  • Stewart Eisenhart