Re: Device Regulation – May Worsen Before It Improves
I can't argue with tighter controls to ensure better, safer products.
This longer approval cycle time is driving companies to look to market outside the US first. If you can get to market faster outside the US, why wouldn't you? And with longer and longer approval times on the horizon, I would expect that trend to continue to increase. So the potential is there, at least, for the US product reputation to tarnish. Not to mention the delay in getting innovative devices to patients in the US!
I think that along with the tighter regulations, we need to also figure out somehow to speed up the process. I'm only on the periphery of RA activities but here's what I often see: you make your submittal and the timer starts. When the timer is about to expire, you get a request for more information. This resets the timer and the loop begins again. I expect device companies try to use this 'technique' to their benefit often by submitting incomplete packages just to get in the queue. So I'm not pointing fingers at either side, just pointing out that there's some inherent issues with the current process that could be exacerbated by additional controls / longer cycle times.
I think the strategy needs to both excising those loopholes miregmgr cites and also to eliminate the non-productive wait times.
Ok, now on to Middle-East peace, solving world hunger, ...