The mission of the United States Food and Drug Administration (FDA) is to Promote and Protect the Public Health. The FDA promotes the public health by delivering to the market in an efficient and timely fashion new and novel drugs, devices and biologics that have been proven effective. It also protects the public health by ensuring these products are safe when used as directed. This Webinar will review the definitions (or lack of) for adverse events within the medical device regulations, focusing on adverse device effects, and the challenges in understanding when events are reportable as adverse events and when they are not. We will cover both the reporting of Adverse Events associated with investigational devices as well as commercially available devices, as well as combination products and in-vitro diagnostic devices. Also covered will be the Institutional Review Boards’ role in recording and reporting of adverse events.

Objectives:

Know the difference between and Adverse Event and an Adverse Device Effect

Understand the terms related to reporting adverse events, e.g. serious, unanticipated, expected;

Recognize the reporting requirements for investigational devices and commercially available devices including combination products

Speakers:

Douglas Albrecht, BSN, CCRA, President, Valiscent Clinical, Inc.

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