Chapter 19

Surveillance and Epidemiology as Tools for Evaluating the Materials used in Medical Devices

Roselie A. Bright ScD

Roselie A. Bright ScD

Epidemiologist

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA

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First published: 02 March 2007

Summary

This chapter contains sections titled:

  • Introduction

  • General considerations that affect the design of epidemiologic studies of materials used in medical devices

  • Example: natural rubber and latex allergy

  • Summary

  • References

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