If a firm distributes a Class III device without an approved Pre-market Approval Application, what is the statutory violation?

Distributing a Class III medical device without an approved Pre-market Approval Application constitutes adulteration. Class III devices are classified as high-risk and require rigorous evaluation and approval by the FDA due to the potential risks they pose to health and safety. The approval process is established to ensure that the device is both safe and effective for its intended use.

When a firm offers such a device without undergoing this approval, it renders the product adulterated under the Food, Drug, and Cosmetic Act. Adulteration generally refers to products that are not manufactured in compliance with the quality standards set by regulatory authorities. In this case, because the device lacks the necessary approval, it is considered unvalidated and non-compliant, which directly impacts its regulatory status.

Other options do not capture the essence of this violation. Improper use refers to actions taken by users rather than manufacturers. Misbranding involves labeling issues that might mislead consumers but does not specifically address the lack of approval status. Lastly, the term "idiocy" is not a formal legal concept within the context of FDA regulations and is not applicable here. Thus, the classification of distributing a Class III device without the proper approval clearly falls under the category of adulteration.