The Revolutionizing Prosthetics program was chosen as the first test case under the recently announced FDA Innovation Pathway program to "facilitate the development and regulatory evaluation of innovative medical devices."
We plan to pursue an Investigational Device Exemption (IDE) to be able to use the Modular Prosthetic Limb (MPL) as an upper-limb prosthesis. The MPL was designed for adaptation to multiple levels of amputation and input specifications allowing control from a variety of sources (i.e., cleared surface electrodes as well as implantable peripheral and central arrays).
Medical Device Innovation Initiative White Paper: CDRH Innovation Initiative (FDA Center for Devices and Radiological Health, February 2011)
FDA's Medical Device Innovation Initiative (FDA, February 8, 2011)