On 08/11/2014 08:03 AM, Ian Jackson wrote:
Steve M. Robbins writes ("Re: Status of uw-prism packaging for Debian"):My guess is that the legality of distribution hinges on how the software is represented. For example, [1] defines "device" as: any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in a. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical sate, or its symptoms, in human beings or animals, ... etc. If the software makes no claim about diagnosis or treatment, perhaps it's still OK, as in the Osirix case.This sounds like it could be dealt with by appropriate wording in the Description and/or documentation (eg manpages) Ian.
I had the good fortune at a recent social event to meet an attorney for one of the big multinational corporations in the medical device business, whose job is to look after FDA regulatory issues. He even was familiar with RTP systems. He agrees with the view that if the Prism software is not represented as a ready-to-use device or system, and is only distributed as a source code library, then no FDA involvement should be necessary.
The way Common Lisp code is packaged in Debian appears to be most suitable to this anyway. Building a runnable binary is highly Lisp vendor specific and would be difficult to automate. But treating it as a library from which someone really knowledgeable could build a binary on their own would be relatively easy. I would support this.
Sorry to have taken the time of so many people to sort this out. If this source only strategy is OK with you all, what are the next steps? Ira -- Ira J. Kalet, Ph.D., FACMI Professor Emeritus, Radiation Oncology Professor Emeritus, Biomedical Informatics and Medical Education Email: ikalet@uw.edu Web: http://faculty.washington.edu/ikalet/ -----------------------