Chapter 2

Medical Device Regulation in the USA

Thomas P. Gross MD, MPH

Thomas P. Gross MD, MPH

Director

Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-520, Rockville, MD 20850, USA

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Celia M. Witten MD, PhD

Celia M. Witten MD, PhD

Director

Office of Cellular Tissues and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration, WOC-1 Building, HFM-700, 1401 Rockville Pike, Rockville, MD 20852, USA

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Caspar Uldriks

Caspar Uldriks

Consumer Safety Officer

Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, OAK4 Building, HFZ-300, 2094 Gaither Road, Rockville, MD 20850, USA

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First published: 02 March 2007
Citations: 1

Summary

This chapter contains sections titled:

  • Introduction

  • Premarket review

  • Marketing applications

  • Postmarket oversight

  • Conclusion

  • References

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