That strikes me as a system that was set up with the best intentions, but which in practice acts as a barrier to, rather than facilitator of, change
Hu?
I can see an argument that is is ineffective (maybe it just drops into the FDA bureaucracy), but I'm not sure how you can argue it is actually a barrier?
The FDA does actually have some pretty significant regulatory authority over medical devices. IANAL, but it appears this may be one of the limited cases where the FDA may actually be able to force a recall[1] as opposed to just requesting it. I suspect (and hope) the "recall" would actually be limited to a software update in this case. Even if they can't force it, a FDA-requested recall is a pretty significant thing.
Hu?
I can see an argument that is is ineffective (maybe it just drops into the FDA bureaucracy), but I'm not sure how you can argue it is actually a barrier?
The FDA does actually have some pretty significant regulatory authority over medical devices. IANAL, but it appears this may be one of the limited cases where the FDA may actually be able to force a recall[1] as opposed to just requesting it. I suspect (and hope) the "recall" would actually be limited to a software update in this case. Even if they can't force it, a FDA-requested recall is a pretty significant thing.
[1] http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDis...