Regulatory authorities allow medical devices to be marketed based upon 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 and retrospective postmarket data derived from devices and conditions that 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 assure that the assumptions and estimates applied during the product development process were accurate and remain accurate throughout the total product lifecycle.
This course highlights the requirements for an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe. It also sets the stage for the future of postmarket surveillance programs by presenting the US Food and Drug Adminstration’s (FDA) Postmarket Transformation Initiative and Global Harmonization Task Force (GHTF) guidance.
Learning Objectives
Upon completion of this course, participants should be able to:
- Describe the role of a postmarket surveillance program on device safety, efficacy, risk management and product development
- Define the regulatory and quality system requirements that address postmarket surveillance in the US, Canada and Europe
- Describe the sources of postmarket surveillance data and their relative strengths and weaknesses
- Outline methods for analyzing postmarket surveillance data
- Identify the various actions that can result from the collection and analysis of postmarket surveillance data
Target Audience
This course is intended for both new and experienced regulatory, medical affairs and quality systems personnel interested in learning or improving their understanding of the current postmarket surveillance body of knowledge.