GG&G

[uksausage]

what is your source of the "within a month or so" for FDA rules to allow accepting RWD?

That is the shortest route to clearance from what I can tell as safety has been addressed it is just evidence of being suitable for pain symptom #3 that will turn it into a general clearance.

from what we were told the survey data couldn't be accepted as evidence until the new rule is there so a clinical trial was required, but that is taking longer than for ever so the RWD rule change should free us up.

do we know if a new separate 501K has to be submitted or is the current one still active?