Final Guidance: Performance Assessments for Quantitative Imaging

New final guidance details information to include in premarket submissions for medical devices with quantitative imaging functions.

If your email program has trouble displaying this email, view as a webpage. FDA Issues Final Guidance about Technical Performance Assessments for Quantitative Imaging in Premarket Submissions Today, 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 The draft guidance of the same name issued on April 19, 2019. Read the Guidance Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA