Regulatory authorities allow medical devices to be placed on the market based on data supporting the reasonable assurance that the proposed device is both safe and effective. These data comprise prospective premarket information generated by using ideal devices under ideal conditions. Retrospective postmarket data derived from devices and conditions may differ from the premarket testing in ways both obvious and subtle. An effective postmarket surveillance program monitors the performance of the full range of actual devices under all actual usage conditions, to ensure that the assumptions and estimates applied during the product development process were accurate and remain so throughout the total product lifecycle.
This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe. In Europe, when reference is made to the EU in medical device guidance documents, this is meant to include the European Economic Area (EEA), Switzerland and Turkey. It also sets the stage for the future of postmarket surveillance programs by presenting the US Food and Drug Administration (FDA) Postmarket Transformation Initiative and Global Harmonization Task Force (GHTF) guidance.