Scientific Publications by FDA Staff

N Engl J Med 2012 Oct 25;367(17):1583-5

Unique Device Identification in the Service of Public Health.

Gross TP, Crowley J

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 ...