robert.beck
Involved In Discussions
Has anyone else found the 510(k) process more difficult now than in the past? I recently submitted a 510(k) for a very low risk device, and got 17 major deficiencies and 1 minor deficiency. Some of them are incredibly picky and several do not have any regulatory or guidance document basis. Further, the reviewer was slightly sarcastic, and has not responded to an email. The deficiency letter gave us 10 days to request a teleconference then went on state limitations about what could be asked during the teleconference, and strongly suggested using the Q-sub process. The Q-sub process involves more paperwork and bureaucracy.
It's going to take a lot of work to respond to some of these 'deficiencies.' One in particular is plainly ridiculous. I am wondering if there is some internal turf battle within FDA that is driving this change.
It's going to take a lot of work to respond to some of these 'deficiencies.' One in particular is plainly ridiculous. I am wondering if there is some internal turf battle within FDA that is driving this change.