Total Product Life Cycle : Post-Market Monitoring Phase

Even after granting marketing authorization for a medical device, the FDA continues to monitor how it performs once it is commercially available. Although pre-market clinical trials provide important information on a device’s safety and effectiveness, it is possible that new safety concerns will emerge once the device is widely used by people. FDA has several programs that allow manufacturers, health professionals, and consumers to report problems associated with approved medical devices to make sure that any safety issues are identified and can be addressed. This ongoing, post-marketing surveillance is critically important to ensuring patient safety. Read about the Total Product Life Cycle here »

Articles in

Post-Market Monitoring

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC created a “How-To” video series to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations...

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

In conjunction with its release of the Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, MDIC issued a short video in which several experts involved in writing the report, including a patient who uses a medical device patient,...

MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report

MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report

This report provides a series of resources to help sponsors maximize patient input in their design and development of clinical trials. In particular, the report offers a series of best practices for device sponsors to identify and engage the “patient voice.”  By...

Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report

Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report

MDIC designed this report to be a practical resource to help professionals across the medical device community discuss medical device benefits, risks, and uncertainty in easy-to-understand language. While investigators, physicians, regulators, and others involved in...

A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology

A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology

The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of...