A retrospective review of the cases brought by the Massachusetts U.S. Attorney’s Office Health Care Fraud Unit between September 2008 and September 2009 reveals a high number of cases involving medical devices as compared to drugs or other medical products. Medical devices include a wide range of products, such as implants, stents, heart pacemakers, fetal monitors, x-ray equipment, and thermometers. They are used in patients for the purposes of diagnosis, therapy or surgery. By definition, medical devices do not achieve their primary intended purposes through “chemical action” and are not “dependent upon being mobilized” to achieve their primary intended purposes. Medical devices often require approval by the Food & Drug Administration (“FDA”) before they may be legally distributed and marketed.

The gamut of products that may be considered medical devices are reflected in the cases brought by the Health Care Fraud Unit over this past year.

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