Pedro,
I may be wrong,
but I think that the correct statement is that software that
is *offered for sale as a medical device* in the US,
requires FDA approval.
Doctors still have the discretion of using the tools that
they deem necessary for treating their patients.
That said, I would discourage
John,
I don't know Canadian jurisprudence on the issue. Here in Brazil it's up to
the physician discretion only if he works in a research hospital, otherwise
the Software must be ANVISA approved.
cheers
PPJ
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Pedro Paulo de M. Oliveira Jun
Hello,
Do you know of any regulations about using FreeSurfer outside of the U.S.,
specifically in Canada?
Thank you,
john drozd
2009/5/25 Pedro Paulo de Magalhães Oliveira Junior
> Software used for clinical purposes need a FDA approval in US.
> FreeSurfer main target is research. If you use i
Software used for clinical purposes need a FDA approval in US.
FreeSurfer main target is research. If you use it for clinical purposes you
are on your own risk.
cheers.
PPJ
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Pedro Paulo de M. Oliveira Junior
Diretor de Operações
Netfilter
*Hello,
I have a question regarding the second statement in the Clinical Use section
of your registration web page.
"Clinical Use: This software may not and should never be used for clinical
purposes. Software used for clinical purposes may require regulatory
documentation and associated filing
