Eaglezsoar wrote:I would wish you the best of luck printing the hand. This could be a Godsend to those who need it but cannot afford the
astronomical prices as they are now. I certainly wish that the 3D printer community could make these and get whatever
approval is necessary to use such a device.
My understanding is that such a device can be "gifted" to an amputee and it does not require any approval. You only need approval if you want to sell them. This is how the Enabling the Future movement (
http://enablingthefuture.org) operates without any official approval, although the FDA has shown them support at conferences. The issue is one of those simple prostheses costs well under $50 to produce, which is a reasonable donation for many people, especially if the donation is split between multiple people by one supplying printed parts and another supplying hardware. In the case of this advanced prosthesis it is not really practical to adopt such a distribution strategy, but for testing it's certainly viable to allow an amputee to try prototypes. That's assuming my theory about FDA limitations is correct, electronic prostheses may have entirely different rules.