Presentations and Graphics
Presentations 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: Research and Quality Improvement activities are different, with a small degree of overlap. This table resource defines some of the differences.
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.
Read MoreEducation – Patient/Caregiver: Two-page patient education resources about LAAC. Includes information about the procedure, risk factors, and post-procedure instructions.
Read MoreEducation – Patient/Caregiver: Extensive collection of patient education sheets for 17 different medications used for anticoagulation, rate control, and rhythm control. Each sheet includes how to take the medication, potential interactions, side effects, and warnings.
Read MoreEducation – Patient/Caregiver: Two-page patient education resource explaining AFib, its causes, management and treatment. Includes a description of medications, procedures, and implantable devices, as well ask suggested lifestyle changes.
Read MoreCare Pathways/CDS: Care pathway for anticoagulation and decision support tool for an AF center.
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