As others have stated, the FDA does not give mandatory tests that need to be done. However, they do enforce that design verification and validation very very strictly (as well as process/software etc.). Here, verification is done to show that the product meets its design specification (it is what its supposed to be) whereas validation is done to show that the product meets the customer needs (is performs its intended use). As a guideline, there are ISO and ASTM standardized tests (e.g. Instron pull tests) but ultimately, engineers just design a test to show prove V&V. For example, the design specification of a balloon is that it can fully inflate to 100cc. To test this, you can put the balloon in a known volume of water, inflate it, and measure the water displacement. Furthermore, they then have to prove that the test is reliable as part of the V&V process (using Gage R&R and other statistics). So they will perform the test across a determined sample size, record the results for each sample, and hopefully have statistically significant test results that prove the the test can be used by any operator with any any sample.