Posted by
Aryeh Weiss on
Dec 24, 2015; 3:09pm
URL: http://imagej.273.s1.nabble.com/validation-for-Helsinki-committee-tp5015279p5015284.html
Hi Curtis
On 24/12/2015 3:01 PM, Curtis Rueden wrote:
> Hi Aryeh,
>
> > A Helsinki committee has asked whether FIji/ImageJ have "validation".
>
> My understanding is that ImageJ would not "have validation" itself.
> Rather, the organization using it for some purpose (e.g., designing or
> manufacturing a medical device) must somehow ensure the software is
> appropriate for that purpose.
>
I think that this is not like FDA approval. Rather, all studies that
involve animals or humans need to pass a local review board. I dont have
the guidelines -- this is what I found.
http://www.tasmc.org.il/sites/en/Research/Clinical-Trials/Pages/Helsinki.aspxMy son is doing his MD thesis using Fiji (guess where he got that
idea...) and this just came up.
I think it has to do with demonstrating fitness for purpose in the
proposed study.
--aryeh
> In the U.S., from the FDA's web site's validation guide [1]:
>
> "Where the software is developed by someone other than the device
> manufacturer (e.g., off-the-shelf software) the software developer may
> not be directly responsible for compliance with FDA regulations. In
> that case, the party with regulatory responsibility (i.e., the device
> manufacturer) needs to assess the adequacy of the off-the-shelf
> software developer's activities and determine what additional efforts
> are needed to establish that the software is validated for the device
> manufacturer's intended use."
>
> Do you have a link to the Helsinki committee guidelines for comparison?
>
> Regards,
> Curtis
>
> [1]
>
http://www.fda.gov/RegulatoryInformation/Guidances/ucm085281.htm#_Toc517237930>
> On Thu, Dec 24, 2015 at 2:46 AM, Aryeh Weiss <
[hidden email]
> <mailto:
[hidden email]>> wrote:
>
> A Helsinki committee has asked whether FIji/ImageJ have "validation".
> This issue was raised a some years ago in this thread:
>
https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4>
> I see that ImageJ is used in many publications which contain
> statements of compliance with Helsinki committee guidelines.
> My question is, has anyone on the list received such a request ,
> and if so, how did you respond?
>
> Thanks in advance
> --aryeh
>
> --
> Aryeh Weiss
> Faculty of Engineering
> Bar Ilan University
> Ramat Gan 52900 Israel
>
> Ph: 972-3-5317638
> FAX: 972-3-7384051
>
>
> --
> ImageJ mailing list:
http://imagej.nih.gov/ij/list.html>
>
--
Aryeh Weiss
Faculty of Engineering
Bar Ilan University
Ramat Gan 52900 Israel
Ph: 972-3-5317638
FAX: 972-3-7384051
--
ImageJ mailing list:
http://imagej.nih.gov/ij/list.html