"...regulated as Class I (exempt) medical devices."
As long as the new device, "...is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology."
This means that most prosthetic devices are not explicitly regulated and are free from regulatory overhead in nearly all cases, especially the 3d-printed ones. While one can speculate on why they chose not to regulate these I think we can assume it's because ostensibly there's no danger to the end-user.
I had the privilege of seeing Dean Kamen speak last year about the DEKA arm. One of the things he lamented was that the FDA had to decided not to classify the arm as Class I, and as such it was getting caught up in drawn out regulation when there were people he felt it could help right now.
Thanks for the link. The DEKA arm is a great piece of tech.
I could speculate that because it relies on new tech and new research into prosthetic devices that the didn't just rubber stamp it.
Part of what the FDA does is safety, and the other part is validating the claims that a device or drug manufacturer makes. It's probably for this reason that they imposed additional regulatory validation. Because a cyborg arm? That HAS to be SCI-FI, right? ;)
http://openprosthetics.wikispot.org/Federal_Regulation_of_Pr...
"...regulated as Class I (exempt) medical devices."
As long as the new device, "...is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology."
This means that most prosthetic devices are not explicitly regulated and are free from regulatory overhead in nearly all cases, especially the 3d-printed ones. While one can speculate on why they chose not to regulate these I think we can assume it's because ostensibly there's no danger to the end-user.