What does "Commercial Distribution" refer to?

The term "Commercial Distribution" is specifically defined in the context of regulatory affairs as the distribution of medical devices that are intended for human use and are offered for sale. This encompasses a wide range of activities where the devices are made available to consumers, healthcare facilities, and other end-users with the purpose of generating sales revenue.

This definition is crucial for understanding how products enter the market and the regulatory requirements they must meet to ensure safety and efficacy for the patient population. By focusing on products that are intended for actual market use, the regulatory framework can enforce guidelines that provide assurance to consumers and maintain public health standards.

In contrast, distributions of devices intended solely for research or those that are investigational in nature do not fall under commercial distribution, as they do not aim at direct consumer sales. Similarly, distribution limited within a parent company pertains to internal handling of products rather than market-wide sales.