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FDA: implantable and other medical devices may harm patients if worn in MR environment

This week, the Food and Drug Administration (FDA) issued a comprehensive guidance document on the testing and labeling of medical devices that might be on the body of patients who enter the zone of the strong magnet when magnetic resonance (MR) imaging scans are administered. Serious harm can occur if such devices enter the "magnetic resonance environment" without precautions in place to prevent unnecessary accidents and harm to the patient.

The guidance contains recommendations on testing to assess the safety and compatibility of medical devices that might on the body of a patient who will be administered MR scans, specifically implanted medical devices; medical devices that are fastened to or carried by a patient (e.g., external insulin pump, pulse oximeter); medical devices that would reasonably be anticipated to enter the MR environment during clinical care; and all medical devices that may enter the MR environment.

On May 20, 2021, the Federal Register announced the availability of the guidance. The FDA stated that the "guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices."

While targeted at device companies, the guidance should be carefully reviewed by all diagnostic imaging suppliers and providers. 

This guidance document provides recommendations on MRI safety and compatibility assessments and labeling information that should be included in premarket submissions (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).

Tags

health care & life sciences, fda, medical devices, diagnostic imaging

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