Medical Device Regulation and Retrieval Analysis

Retrieving and analyzing medical devices from revision or removal surgeries are critical activities for understanding device failures. However, the role of retrieval analysis should not be limited to the investigation of individual failures and subsequent root cause analysis. Implementation of retrieval programs that operate throughout the commercial life of devices can be a means by which manufacturers inform product development, augment regulatory submissions, evaluate and mitigate risks, implement continuous improvement, and develop new designs or product enhancements. Understanding how retrieval analysis can contribute to the Total Product Life Cycle of a device will enhance a manufacturer's ability to address regulatory requirements and U.S. Food and Drug Administration inquiries, identify and respond to unanticipated failure modes, evaluate successful in vivo performance of its devices, and to improve the quality, safety, effectiveness, and performance of new devices. We will review some of the basic scientific and regulatory requirements that apply to devices in the context of retrievals. We will also examine the role of retrieval analysis during device development within the design control framework and will provide guidelines for implementing a formal program that will allow manufacturers to realize the benefits of retrieval analysis throughout the Total Product Life Cycle of a medical device.