FDA approval is contingent on so many factors that even if it was entirely open source, including all hardware design and the instructions for assembly, maintenance, and manufature it would be entirely plausible for it to lose approval if the company responsible for continued development went bankrupt.
Without approval, no reputable surgeon will do anything beyond remove it.
A device not having a clear and unambiguously documented path for addressing defects found in the future is more than sufficient reason to lose approval.
I guess I don’t see how a surgeon being unwilling to do maintenance on a non-FDA approved medical device is fucked up.
If it fails to meet the criteria for being safely used in a medical context, it’s irresponsible to try to maintain it.
FDA approval is contingent on so many factors that even if it was entirely open source, including all hardware design and the instructions for assembly, maintenance, and manufature it would be entirely plausible for it to lose approval if the company responsible for continued development went bankrupt.
Without approval, no reputable surgeon will do anything beyond remove it.
A device not having a clear and unambiguously documented path for addressing defects found in the future is more than sufficient reason to lose approval.
That’s fucked up then
I guess I don’t see how a surgeon being unwilling to do maintenance on a non-FDA approved medical device is fucked up.
If it fails to meet the criteria for being safely used in a medical context, it’s irresponsible to try to maintain it.