April 25, 2019

FDA Releases Draft Guidance on Quantitative Imaging

On April 19, 2019, the U.S. Food and Drug Administration (FDA) released its draft guidance, “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” Public comments are encouraged by June 18, 2019.

Quantitative imaging functions extract information from medical images in the form of numerical values, such as standard uptake values in nuclear medicine, relaxometry in magnetic resonance and other measurements used in various radiology modalities.

In its draft guidance, the FDA recommends that manufacturers provide additional information in their premarket submissions for medical devices with quantitative imaging functions because of their impact on clinical decision making and susceptibility to systemic error and random variation. The FDA asked for additional information to more adequately describe the functions, to acquire performance specifications to ensure their safety and effectiveness, and to provide enhanced product labeling to users.

Questions or feedback from ACR members on the draft guidance should be directed to Gloria Romanelli, JD, ACR senior director of legislative and regulatory relations, gromanelli@acr.org, or Michael Peters, ACR director of legislative and regulatory affairs, mpeters@acr.org or (202) 223-1670.