In my opinion, 99% of the time companies do not violate FDA regulations on purpose. The companies are aware that violating these regulations can lead to both poor reputation and failure to get approval. However, abiding by all the regulations set by the FDA is not easy, especially when there are so many moving parts to medical device projects. Small mistakes in meeting regulatory guidelines can be ignored and eventually turn into much larger problems. At the same time, companies are always trying to reduce costs. In order to reduce costs, companies sometimes take shortcuts and try to rush through clinical trial processes. Also, the sheer amount of documentation needed can be another potential issue for companies, especially if they do not have an up-to-date trial master file.