I broad terms I agree that there's probably too much regulation on medical devices in general. There are a variety of areas where there can be considerable stre

I broad terms I agree that there's probably too much regulation on medical devices in general. There are a variety of areas where there can be considerable stream lining or reduction to the net benefit of all parties involved. That said, the myoelectric device at a minimum falls under some level of regulation since it is a biopotential device. The moment you start measuring potentials on the human body, you add the risk of injecting current across the human body - obviously bad. If you wanted to ensure that the myoelectric device was safe, you would at a minimum ensure that a) sufficient isolation between the sensory and actuator circuits b) a safe sensory circuit. Now, while doing that is probably relatively trivial to actually design, you do need to verify it. So, once again, I agree that there's probably too much regulation piled on, but there is a good reason to regulate/verify in some form or way at least the myoelectric device. More generally, notice that the examples that you and sister component pointed out are relatively simple, especially compared to a prosthetic hand. Complexity in itself can cause the need for regulation. Oh, and on the side, you may find this document with regards to impact resistant and safety glasses (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070579.htm#3 http://www.fda.gov/medicaldevices/deviceregulationandguidanc...) a fun read =P.