Continuing on from the examples listed above - it very much depends on the type of approval you are going for.Very generally - is it a new drug? Therapeutic? Depending on class designation a BLA could have a set pdufa date set for 6 to 12 months. Is it a Device? Food? A device that's used inside a person? A software? What approval are they going for? Any designations that would speed up review? Does the manufacturing site need to be inspected? Do they need an advisory board committee meeting? Do they need to agree on labeling? How much clinical data is there? How complicating is the data? Etc.
My understanding is this is a 510(k) submission which takes up to 90 days. This is software after all - not anything as complicating as above.
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
Nor advise, dyor
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