Hi Roberto,

After doing some research, I was able to find that the FDA does not demand specific tests, but establishes guidelines for developing design controls, design validation, and design verification. Looking through the site briefly it seems that much of the information provided is definitions and guidelines to allow for an engineer to develop the appropiate tests for their project.

The information I found can be accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm#_Toc382720788

-Andrew Nashed