Posted by Robin on January 09, 1998 at 17:21:25:
In Reply to: Re: Outline posted by Steve Santen on January 09, 1998 at 11:48:44:
Excellent questions, Steve! I'm not sure I know enough yet to provide any definitive answers, but I think it's a pretty safe guess that the FDA's Center for Devices and Radiological Health (CDRH) would be the primary branch of FDA reviewing the encapsulated devices themselves (link below).
Given that, I suspect that that CDER (or something under it's will be the ones to quality test the material contained in the device(s) to ensure it meets regulation standards (the regulations they're developing/revising which the meeting was set up for). Given that, #3 in my first message may be poorly worded. I hope that anyone who reads that message also reads this one.
There may be other FDA subagencies involved too. I just came across the FDA's Center for Devices and Radiological Health