Medical Devices: Postmarket Surveillance
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.
At a Glance
- 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.
- Learning Level: Basic
- Total Length of Course: 4 Hours
- RAC Points: 4
- Medical Device Certificate Elective
- Enrollment Period: 12 months
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
Lesson Titles
- Lesson 1: Importance of Postmarket Surveillance
- Lesson 2: Postmarket Distribution Records
- Lesson 3: Postmarket Surveillance Regulatory Requirements
- Lesson 4: Sources of Postmarket Data
- Lesson 5: Assessment of Postmarket Data
- Lesson 6: Actions Related to Postmarket Data
- Lesson 7: CDRH “Condition of Approval” Studies
This course is also included in:
