510ks have a 90 day timeline. The FDA can "stop the clock" to ask for more information and clarification. Buts its 90 days from submital to approval or rejectio

510ks have a 90 day timeline. The FDA can "stop the clock" to ask for more information and clarification. Buts its 90 days from submital to approval or rejection if your paperwork is in order. Novel devices have a different path. Once cleared the FDA can and will come by at anytime and do an audit of your processes and if they aren't up to snuff they can shutdown sales. Its a trust but verify system.