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Re: FDA Validation a Threat to Free/OSS?
by Arnaud LE BRETON on Tuesday April 16, @06:49AM
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For those of you who are not aware of it, there is also an older
document (from 1999 but still valid) about "Off-The-Shelf Software Use
in Medical Devices" located at :
http://www.fda.gov/cdrh/ode/guidance/585.html
From my understanding, any device/system needs to follow the described
rules for development in order to be approved by the FDA. However how
deep one needs to document the development process is related to the
level of consequence of the system, i.e. a life critical device
directly connected to a patient needs thorough documentation and more
testing than a less critical one.
A solution could be to create a structure, or use an existing one in
order to go through the process of documenting and testing GNU/Linux
(maybe a given kernel, a given version of GCC, all the associated GNU
tools, etc), so that everyone interested in using Linux could then
refer to this effort and participate as new elements would be added to
the pool of software.
A list of device actually using Free-software and approved by the FDA
would be a first step toward this.
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