There is a disconnect between best practice for final testing, such as field testing or beta testing, and what can be done with medical device software. For instance, one official definition of beta-testing is that it is done in the field with pre-release software with a limited set of customers/users. How does this fit with a typical design control scenario, where the software is released as a product after extensive verification/validation but because of its complexity requires clinical use to learn about potential issues/problems? Is a small clinical trial a valid method? Does anyone have any ideas or experience with FDA regarding this type of situation?