Not to be mean Tanya, but that answer had absolutely nothing to do with the question. However to your defense the question had absolutely nothing to do with TestComplete.
As far as I know, FDA (Food and Drug Administration) approval has nothing to do with the test tool used, but rather with what tests are done on the software itself. The software itself has to undergo stringent development cycle as described here:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm