3 ms·
Just to extend off the other replies, the license might also be a factor. GPLv3 has an anti-TiVo, "you must let your users apply their changes to hardware" clau
by oliwarner 7y ago
Just to extend off the other replies, the license might also be a factor. GPLv3 has an anti-TiVo, "you must let your users apply their changes to hardware" clause. FDA might consider that too risky.
- belorn 7y agoThe anti-TiVo clause has some major exception since it is designed to address a very specific scenario; One where the the owner can update the device but only through the approval of the device manufacturer through signed updates. That create two cases where GPL have no issue with DRM. The first case is when no one can update the device because there is no update mechanism. The second case is when there is DRM, and the device can be updated, and the manufacturer give the owner the power to inject their own keys. Again this is allowed. FDA should have no issue with the first case. It may have a issue with the second case if the update allows for changes which impact the medical safety of the device (but not technological security, as there is an exception for that by the fda).