Due to the fact that the medical device industry has such a wide variety of devices, FDA uses an “umbrella” approach for defining the regulation. In other words, the regulation is written very generically and broadly as not to exclude device type or application. In some respects this approach is beneficial for medical device manufacturers because it allows them flexibility of how they want to implement design controls in their organization. On the other hand, even though FDA does not specify details of how each part of the regulation should be implemented, they do have basic expectations that have come to be known as best practices in the industry which FDA inspectors will expect to see during their inspections. To best understand these expectations, manufacturers can tap into various resources such as specialized consultants or other resources such as this book.