From: "Joseph Dal Molin" <[EMAIL PROTECTED]> > Actually this has nothing to do with open source .... it is how it is > distributed ie. sold vs. given away. > Actually it appears to have nothing to do with the method of distribution as explained in http://www.fda.gov/cdrh/ode/guidance/337.pdf
"This guidance applies to software devices regardless of the means by which the software is delivered to the end user..." The question of FDA regulation has to do with the classification of the software, whether it constitutes a medical device or not. In order to avoid a 510k submission, one must show that the software is simply an information processing product and not a medical device. One then must ask the question: At which point does a product become a medical device? Is a graphic display program any different than a text display program? How are medical outcomes affected by failures in the software device? Is there additional risk to the patient? Would an image conversion product necessarily be a medical device? If DICOM data could be converted to a TIFF or JPEG and displayed by available software, would this solve the problem of regulation? One might then be forced to look at the issue of SOUP (Software of Unknown Pedigree) in the software device. I wonder if all OS software must be treated as SOUP, since there are few if any formal controls on design, let alone V&V. Mike ------------------------------------------------------- SF.Net email is Sponsored by the Better Software Conference & EXPO September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf _______________________________________________ Hardhats-members mailing list Hardhats-members@lists.sourceforge.net https://lists.sourceforge.net/lists/listinfo/hardhats-members
