Devices

MR Testing, Labeling Guidance

FDA has issued a draft guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, with the agency’s recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance environment. The document also has the recommended format for magnetic resonance imaging safety information in medical device labeling.

When finalized, the guidance will supersede a 12/11/14 guidance. It applies to all implanted medical devices, external medical devices that are fastened to or carried by a patient, such as an external insulin pump, and all medical devices intended to enter the MR environment. It does not apply to the MR system. It has recommendations on MR safety and compatibility assessments and labeling information that should be included in PMA, HDE, and IDE applications, 510(k) submissions, and de novo requests.

Guidance contents are Introduction, Scope, Terminology, Relevant Standards and Guidance Documents, Addressing Hazards for Medical Devices in the MR Environment, Reporting Results, MRI Safety Labeling, and two appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome