Unique Device Identification in the Service of Public Health

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Abstract
The Food and Drug Administration (FDA) regulates medical devices and electronic radiation-emitting products — goods that range from single-use disposables, to short- and long-term implantables, to multiple-use durable capital equipment. Medical devices encompass products that are low risk (class I), such as tongue depressors and prescription eyeglasses; moderate risk (class II), such as magnetic resonance imaging devices and large-volume infusion pumps; and high risk (class III), such as drug-eluting coronary stents and immunoassays for hepatitis B antibodies. Of ever-increasing importance to health care, medical devices pose substantial regulatory and public health challenges, given their heterogeneity and inherent complexity and the iterative nature of their development throughout their life cycle.

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