This message was posted by a user wishing to remain anonymous
Dear Raps Community,
I am writing regarding the issue in compiling the data for some section for the 510(k) in eSTAR format.
With the new eSTAR format, i am combining selected predicate device summary with prepared device substantial equivalence for the purpose of reference, in older format this was was provided seperately without merging the predicate devcie summary in substantial equivalence document, but eSTAR do not gives option to attach the predicate device summary. Although, eSTAR gives options to mention which predictae devcie has been selected.
Similary, it is same for all other section, where i am preparing separate document for general description for every eSTAR section, but we have multiple data for each section but the eSTAR section only allow one attachement for example Bench testing section.
I would really apprecite experts thoughts on the above query.
Best,
I would really appreciate your thoughts on this issue ,