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