> Why is the company even involved in the process? They produce a new product and it initially gets a label that says it hasn't been tested, which will rightful

> Why is the company even involved in the process? They produce a new product and it initially gets a label that says it hasn't been tested, which will rightfully deter customers when most existing products don't have that label. The government performs its testing to check if it's harmful, prioritizing based on which new products are expected to be popular, and once published their results go on the label one way or the other. This a fundamental point of misunderstanding. The government in case of the FDA doesn't test products. They just review the documentation that manufacturers submit. In case of medical devices which are similar to an existing approved medical device (a 410k) for instance the FDA charges $21,760 for this review ($5,440 if you are a small business) and under law has to have the review complete within 90 days. To compare: performing just one of the required tests such as biocompatibility often costs more. The FDA also doesn't write labels for you. That is entirely your responsibility as a manufacturer and frankly impossible without having complete insight into manufacturing and design.