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

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

REFERENCES

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