[Insight-developers] FDA Documents

[Luis Ibanez]

Hi

For those in desperate need of reading material
here are the references to the FDA documents
concerning the use of software in medical devices.

(1) General Principles of Software Validation; Final Guidance
for Industry and FDA Staff
http://www.fda.gov/cdrh/comp/guidance/938.pdf

2) Guidance for Off-the-Shelf Software Use in Medical Devices; Final
http://www.fda.gov/cdrh/ode/guidance/585.pdf

(3) Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices; Final
http://www.fda.gov/cdrh/ode/software.pdf

We will discuss briefly this topic at the meeting,


    Luis