FDA Update

Periodically the FDA issues Guidance documents for 510(k) submissions. here is a recent one for Radiological devices.

FDA Issues Final Guidance about Technical Performance Assessments for Quantitative Imaging in Premarket Submissions

The U.S. Food and Drug Administration (FDA) issued the final guidance, Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions. This final guidance provides the FDA’s recommendations on the information and assessments that should be included in a premarket submission for radiological devices with quantitative imaging functions.

The draft guidance of the same name was issued on April 19, 2019.

Questions?

For more information on the FDA Final Guidance, please email us at: [email protected] and ref: Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.