FDA Medical Device Training

The Food and Drug Administration (FDA) is responsible for the safe regulation of medical devices, such as external defibrillators, cochlear implants, glucose testing devices, and ventricular assist devices. In order for medical, research, pharmaceutical and administrative professionals to learn about and stay apprised of regulation, reporting and responsibility guidelines, the FDA offers a variety of training programs.
  1. Programs

    • The FDA's Center for Devices and Radiological Health (CDRH) offers a variety of training modules that educate students in medical device regulations. Courses are available through online format to provide a convenient method of learning and keeping up to date with regulations, inspections and computer applications.

    Curriculum

    • Course options include an overview of regulatory requirements, an introduction to medical device recalls, CDRH-regulated software and bio-research monitoring. Students learn about what devices are regulated by the FDA, including electrocardiographs, endoscopes and replacement heart valves, device classifications, and special controls.

    Assessment

    • Each student's progress is assessed through a post-module test. Students who obtain a passing grade of 80 percent or better receive a certificate of completion for each course.

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