One of the main differences between 510k and a technical file is the risk management file. Although, ISO 14971 requires a risk management file to be submitted regardless of where the medical device is being sold. The US FDA doesn’t require a risk management file as part of the 510k submission. The US FDA only requires it if the device contains a software and the risk is at least a moderate concern. It can be argued, that each company is required to perform a risk analysis on their product, however it is not required to be submitted with 510k