On Mon, 2007-06-18 at 23:21 -0400, Daniel Drake wrote:
> Let's take a certain class of medical devices into account: ones that
> are absolutely definitely for medical treatment, but are not life
> threatening if they fail.
>
> Say, a dental treatment device -- if the device produces a crown or
> bridge that doesn't fit properly, the dentist says "nope" and throws it
> away. No harm done.
I've done quite a bit of research, I'm not nearly done.
These regulations (from what I can tell) seemed to follow suit with the
National Electric Code (NEC) [latest] when dealing with mandatory
isolated ground devices and special cabling methods when it comes into a
device touching a patient. If that remains consistent, this won't be so
bad.
If the patient never comes in contact with it, its not regulated as much
and (from what I've seen) has no requirement for tamper proofing. I
point out again, I am not _nearly_ done with my research.
I think of nothing else, anyone with an interest should closely monitor
how these devices are being regulated by the FDA as more of them begin
to look like penguins.
I won't argue one way or another as to the presence of benevolent intent
in those laws-to-come, I'm simply pointing out the questionable
technical competency of those who will be writing them and their need
for guidance when doing so.
Best,
--Tim
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