FDA Posts Draft Guidance on “Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions”

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions. As medical imaging continues to evolve, quantitative imaging – the extraction of information from medical images in the form of numerical values – is increasingly used to assess the severity, degree of change, or status of a disease, injury, or condition.

Quantitative imaging is best leveraged when the performance of the quantitative imaging function is well described, and users have enough information to understand the quantitative values being reported. To that end, this draft guidance outlines proposed recommendations

to help industry improve the consistency of information and technical data supporting quantitative imaging functions in medical devices. This draft guidance is not final nor is it in effect at this time.

Read the Guidance

This draft guidance

Applies to all devices that generate quantitative imaging values.
Provides the FDA’s proposed recommendations on the information to include in a premarket submission including function description, technical performance assessment, and labeling of devices that incorporates quantitative imaging function(s).

When finalized, this guidance document will improve the consistency of information and technical data supporting quantitative imaging functions in premarket submissions.

Submit Comments on the Draft Guidance

We encourage manufacturers to become familiar with this draft guidance and provide comments at https://www.regulations.gov under Docket Number FDA-2019-D-1470 or by clicking the button below. Please submit comments for consideration by June 18, 2019 (60 days after publication).

Submit Comments