Presentations and Graphics

FDA and Device Regulation

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.

FDA Medical Device Advisory Committee Presentation

Presentations 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.

FDA Collaborative Communities and Early Feasibility Studies

Presentations and Graphics: Slideshow presentation that explores collaborative communities, early feasibility studies, and the EP EFS initiative.

FDA Investigational Device Exemptions IDE and IRBs

Presentations 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.

Distinguishing Research from Quality Improvement

Presentations and Graphics: Research and Quality Improvement activities are different, with a small degree of overlap. This table resource defines some of the differences.

Device Recall Basics & Challenges: FDA Role, Risk Mitigation, Removals and Corrections

Presentations 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.

AFib Toolkit: Left Atrial Appendage Closure

Education – Patient/Caregiver: Two-page patient education resources about LAAC. Includes information about the procedure, risk factors, and post-procedure instructions.

AFib Patient Education Toolkit: Blood Clot Prevention, Rate Control, Rhythm Control

Education – 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.

AFib Toolkit: What is Atrial Fibrillation

Education – 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.

AF Center Anticoagulation Pathway

Care Pathways/CDS: Care pathway for anticoagulation and decision support tool for an AF center.