Final answer:
Distributing a Class III medical device without an approved Pre-market Approval Application constitutes a statutory violation of adulteration under the Food, Drug and Cosmetic Act.
Step-by-step explanation:
If your firm commercially distributes a Class III device that is subject to PMA requirements without an approved Pre-market Approval Application, the statutory violation is A) Adulteration. According to the Food, Drug and Cosmetic Act, a device is considered to be adulterated if it does not have an approved PMA, which is required for Class III devices to ensure safety and effectiveness. This approval process is essential because Class III devices support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.
as required for Class III devices subject to PMA requirements. The device is considered misbranded because it lacks the necessary FDA approval to be distributed commercially.
Examples of misbranding include labeling a device with false or misleading information, failing to provide adequate instructions for use, or not including required warnings on the device's labeling.