What is the consequence of distributing a Class III device without PMA approval?

Distributing a Class III device without prior approval from the FDA through a Premarket Approval (PMA) represents a statutory violation because Class III devices are subject to the highest level of regulatory scrutiny. These devices are typically associated with the highest risk to patients and are required to undergo rigorous testing and evaluation before they can be marketed. The PMA process is designed to ensure that these devices are both safe and effective for their intended use.

Without such approval, the distribution is not compliant with the regulations that govern medical devices, which can lead to serious legal repercussions for the manufacturer or distributor. Regulatory authorities can take enforcement actions against entities involved in the sale or distribution of unapproved devices, thus categorizing their activities as unlawful.

While the other options may relate indirectly to the distribution of unapproved devices, they do not encapsulate the immediate legal consequence as directly as the statutory violation does. Financial penalties may arise from such violations, and distributing such devices could potentially harm patients, but the foundational issue is that such actions violate established laws. Mandatory recalls may also follow, but they are generally a reactive measure after a violation has already occurred. Therefore, identifying the act itself as a statutory violation clarifies the legal nature of the issue.