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
-----------------------------------------------------------
Pedro Paulo de M. Oliveira Junior
Diretor de Operações
Netfilter & SpeedComm Telecom
--- Novo Netfilter 3.0 www.netfilter.com.br



2009/5/25 John Drozd <john.drozd@gmail.com>
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 <ppj@netfilter.com.br>

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
-----------------------------------------------------------
Pedro Paulo de M. Oliveira Junior
Diretor de Operações
Netfilter & SpeedComm Telecom
--- Novo Netfilter 3.0 www.netfilter.com.br



2009/5/25 John Drozd <john.drozd@gmail.com>
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 filings."

Does the statement  "
Software used for clinical purposes may require regulatory documentation and associated filings." mean that a version of FreeSurfer can be used for clinical work?

Thank you for your time,
john drozd

_______________________________________________
Freesurfer mailing list
Freesurfer@nmr.mgh.harvard.edu
https://mail.nmr.mgh.harvard.edu/mailman/listinfo/freesurfer