FDA Regulation of Medical Devices Used in Intervention and Related Legal Issues

John J. Smith

doi:10.1055/s-2001-19102

Seminars in Interventional Radiology, Table of Contents

Semin intervent Radiol 2001; 18(4): 405-414
DOI: 10.1055/s-2001-19102

FDA Regulation of Medical Devices Used in Intervention and Related Legal Issues

John J. Smith

Department of Radiology, Harvard Medical School, Cambridge, Massachusetts, and Center for the Integration of Medicine and Innovative Technology, Department of Radiology/Massachusetts General Hospital, Boston, Massachusetts

Abstract

ABSTRACT

The United States Food and Drug Administration (FDA) has developed a complex, comprehensive system to ensure that medical devices are safe and effective according to their approved indications. It is not a system that is easily understood by physicians. A concern among interventionalists is that relatively common clinical practices violate federal law. This article discusses the low risk of regulatory action physicians face in several common patient treatment scenarios, including use of unaltered devices for non-FDA-approved clinical indications and physician modification of medical devices. The use of devices distributed under an investigational device exemption is also discussed. Finally, the primary legal exposure interventionalists face in their everyday practice, namely negligence and informed consent actions, is described and analyzed.

KEYWORD

Medical devices - intervention - Food and Drug Administration

Full Text

References

REFERENCES

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