There are big differences between the Design History File, 510k Submission, and the Technical File. The design history file is an FDA regulation that talks about the design controls and the changes and additions that have occurred from the time of conception. These files feed into the 510k and technical files but are itself a hefty file of design and development in the safety of the product.

The 510k is a path of FDA clearance that products take that most class II devices take. The point is to demonstrate to the FDA that the product is similar to an already approved product. This is a good way to speed up the process, however, the device is still susceptible to FDA inspection at any time.

Lastly, the technical file is similar to the 510k but used in device approval abroad. The file also requires a clinical evaluation report that addresses the investigation, risk, and post-market information.