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

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

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 anyone from using in a clinical application any software that has not been developed under a stringent quality control process.

Regards,

Luis

--------------------------------------------- 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

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