Posted by Robin on January 09, 1998 at 17:23:02:
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 National Center for Toxicological Research which may have some influence somewhere in all of this too, but I'm a bit rushed this afternoon. I doubt you'd go wrong in assuming that once the encapsulated material and device get the green light from CBER and CDRH, the final stamp of approval is issued by the FDA administrative office and the product is released to the general public. This seems the logical guess to me, but I am just guessing! I'll research this further as time allows.
Robin (hoping my hasty HTML code copies right)
Ha! It didn't, of course. ;<