Questions:
How can we handle the following situations:
1) We want to use one device as our predicate device. But there is only statement in FDA premarket notification database. How can we get the more information lik summary? We should request this information to FDA or to the predicate submitter.
2) We want to use one device which is cleared in the past 2 years as our predicate device. But neither summary nor statement is available in the FDA's database. How can to get the summary or statement?
3) For the
510k application document to be submitted to FDA, do we need to add the predicate's 510k summary or statement into the application files?