Safety
This resource outlines a standardized policy for safely performing MRI examinations in patients with legacy (non–MR conditional) or mixed cardiac implantable electronic device (CIED) systems. It defines patient eligibility criteria,…
Read MoreThese documents describe an IRB-approved research study and clinical safety workflow that allows patients with pacemakers/ICDs (CIEDs) to undergo clinically indicated MRI with standardized monitoring, device programming, and follow-up, while…
Read MoreThis patient-facing educational handout explains the process, risks, and safeguards involved when patients with legacy (non–MRI-conditional) pacemakers or implantable cardioverter defibrillators (ICDs) undergo MRI imaging. It is designed to support…
Read MoreThis patient-facing educational resource explains the Convergent Hybrid Ablation procedure for atrial fibrillation, a two-stage treatment option designed for patients with persistent or long-standing AF who continue to have symptoms…
Read MoreThis patient-facing educational handout provides clear, step-by-step guidance to help reduce infection risk and support optimal recovery for patients undergoing implantable cardiac device procedures. Designed for use before pacemaker, ICD,…
Read MorePresentations and Graphics: In this slideshow presentation, the learner will explore the mission and history of the FDA and Center for Device and Radiological Health (CDRH), how the CDRH and FDA contribute to a device’s classification, approval, and post-approval maintenance, and an overview of the Total Product Lifecycle Advisory Program Pilot.
Read MorePresentations and Graphics: In this presentation, the learner will explore the purpose and structure of a medical device advisory committee, how they function, and recent guidance.
Read MorePresentations and Graphics: Slideshow presentation that explores collaborative communities, early feasibility studies, and the EP EFS initiative.
Read MorePresentations and Graphics: Slideshow presentation that explore what an investigational device exemption is, significant risk versus non-significant risk device studies, and how IRB’s and the FDA factor in to decisions around device studies.
Read MorePresentations and Graphics: Succinct presentation slides exploring heart rhythm device recalls, FDA’s roles and responsibilities relating to recalls, and recall communications. Also includes risk assessment and mitigation for recalled devices.
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