FDA New 510(k) MRI Device Submission Guidance.

FDA issued a revised and final guidance: “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices” November 18, 2016 to replace the 1988 guidance.

Section 4.2.2 requests a description of how cardiac and peripheral nerve stimulation control is implemented including discussion of software mechanisms to limit gradient output and how the operator is notified if peripheral nerve stimulation is possible.

Section 4.2.8 Image Processing indicates that the software is generally considered Moderate Level of Concern and refers to the general, OTSS, and cybersecurity FDA software guidances. This section also requests detailed information for each image processign feature telated to algoirthms, inputs and data formats, level of user interactio, outputs and how they are displayed.

Section 9.2.7 requests a summary of post processign features and the the software version.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.