On August 2, 2019, the FDA issued a docket requesting comments regarding the magnetic resonance (MR) environment and device safety. The proposed rule recommends expanding testing for "all implanted medical devices, external medical devices that are fastened to or carried by a patient (e.g., external insulin pump), and all medical devices that are intended to enter the MR environment." It suggested standardized labeling for the device to include MR safe, MR unsafe and MR conditional. These are defined within the proposed guidance. To see the guidance please view: https://www.fda.gov/media/129541/download
To submit comments on “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", by October 1, 2019, please click here:
Comentarii