Just ignore the enormous risk or cost. Or how the EU does it (only slightly faster) for one moment. Given that you, the creator, define the risk (dMFEA [1]) AN

Just ignore the enormous risk or cost. Or how the EU does it (only slightly faster) for one moment. Given that you, the creator, define the risk (dMFEA [1]) AND the "quality system" [2] (which is actually a process and has little to do with QA from a software definition or understanding), my guess is that the entire system for approved devices, drugs, and their requisite clinical trials has evolved for the big guys to eat the medium guys and prevent the small guys from even entering the competition. The final nail in the coffin is that there is ABSOLUTELY NO 3rd party risk or security analysis at any time or level - only what you say, document, and submit (claims [3]). They are only involved once there's a lawsuit - and every piece of documentation by the creator is "burden of proof" than the accuser must disprove. Now imagine a 10,000 patient study - how do you prove the drug was bad because it, e.g. blinded one person? [1] https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis https://en.wikipedia.org/wiki/Failure_mode_and_effects_analy... [2] http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/ http://www.fda.gov/medicaldevices/deviceregulationandguidanc... Edit: add claims in parens [3] http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111124.htm http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/u... Edit 2: Short answer, no. But there may be hope for simple pure-software app developers: http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pd...