One of the things FDA reviews (or is supposed to review) prior to clearing or approving drugs or medical devices is the risk resulting from misuse. Something which is easy to misuse or where there would be severe consequences resulting from misuse is supposed to be mitigated prior to clearance/approval.
FDA also requires (or is supposed to require) that manufacturers keep track of this post-market, so if the probability of misuse or severity of harm resulting from misuse is higher than expected, that can also trigger corrective actions (recalls and withdrawals of approval in the most severe cases).
Though of course, as we've seen, the normal rules completely went out the window for this thing. Which considering all the stupid shit I had to implement in (far less dangerous) medical devices to prevent (far less harmful) misuse kinda pisses me off.
One of the things FDA reviews (or is supposed to review) prior to clearing or approving drugs or medical devices is the risk resulting from misuse. Something which is easy to misuse or where there would be severe consequences resulting from misuse is supposed to be mitigated prior to clearance/approval.
FDA also requires (or is supposed to require) that manufacturers keep track of this post-market, so if the probability of misuse or severity of harm resulting from misuse is higher than expected, that can also trigger corrective actions (recalls and withdrawals of approval in the most severe cases).
Though of course, as we've seen, the normal rules completely went out the window for this thing. Which considering all the stupid shit I had to implement in (far less dangerous) medical devices to prevent (far less harmful) misuse kinda pisses me off.