TUNNELL GOVERNMENT SERVICES
MRI Compatibility Consultant (Part-time) (Finance)
Tunnell Government Services (TGS) Understanding of FDA Requirements for
Magnetic Resonance Imaging (MRI) Compatibility Subject Matter Experts (SME)
Requirement: The Office of Product Evaluation (OPEQ) within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) requires "on-call" MRI Compatibility SME support. MRI Compatibility SMEs will be responsible for evaluating the safety of selected medical devices in an MRI environment. These evaluations will be required when Product Sponsors submit regulatory applications (e.g., Emergency Use Authorization [EUA], 510(k) application, Pre-Market Evaluation [PMA] application) to the FDA that include medical devices that may be exposed to an MRI environment.
MRI Compatibility Background: As stated in the May 2021 document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. Guidance for Industry and Food and Drug Administration Staff. 2021 (Link), the FDA developed this guidance to provide the FDA's recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance document applies to all medical devices that might be used in the MR environment, to include all 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 are intended to enter the MR environment.
Expertise in a broad range of MRI Compatibility areas is desired; however, OPEQ has identified 3 key areas where MRI Compatibility SME support is required:
Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.