The FDA has repeated said that the difference of a device from other
non-regulated software is whether its control capability has the inclusion
of an open cognitive loop that precedes the control of a device. In any
particular situation the can be consulted to determine whether this
control criterion has been met. Display software (text or otherwise) that
involves human interpretation is generally considered and open loop.
On Thu, 11 Aug 2005, Michael D. Weisner wrote:
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
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