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Is Software code documentation required for FDA premarket submissions?

#1
Hi everyone,

Does anyone know if software code documentation is required for FDA premarket submissions? It's not entirely clear. Can somebody provide some advice?
 
#3
Does anyone know if software code documentation is required for FDA premarket submissions? It's not entirely clear. Can somebody provide some advice?
In short: software documentation (risk analysis, requirements, design specification, verification & validation) will likely be included in your submission. ...but submission of the actual source code does not need to be included.
 
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