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109.

Issues Regarding Medical Devices and Adulteration Or Misbranding Claims

Cases against regulated firms are usually rooted in allegations that the products sold are "adulterated" or "misbranded" under the FDCA. A variety of factors must be considered in evaluating adulteration and misbranding claims. For example, an overview of the factors affecting medical "devices", and the complex medical device clearance and approval scheme, is included. See this manual at 110 Civil Resource Manual at 110.

It is important to recognize that FDCA offenses are not always easily understood by jurors. A sample indictment in a case based on the medical device laws is included in this manual at 111 Civil Resource Manual at 111. Prosecutors frequently base charges on relatively easily understood FDCA provisions. See this manual at 112 Civil Resource Manual at 112.

[cited in USAM 4-8.225]