Technologies for Smart Sensors and Sensor Fusion

5	Translating Sensor Technology into the Medical Device Environment

Robert D. Black

CONTENTS

5.1    Introduction

5.2    FDA Process for Medical Devices

5.2.1    How the Device Is to Be Used

5.2.2    Safety and Efficacy

5.2.3    Establishing a Predicate

5.2.4    Regulatory Pathway

5.2.5    Independent Device Testing

5.2.6    Some Specific Examples of Sensor Characteristics That Evoke Regulatory Decision Points

5.3    Glucose Sensing

5.4    Capsule Endoscopy

5.5    Cochlear Implant

5.6    Current Trends in FDA Regulations

5.7    Summary

References

5.1  INTRODUCTION

The translation of a sensor technology into clinical medicine is a complex and multifaceted undertaking [1, 2, 3 and 4]. In addition to challenges in the discovery phase, there ...