Subject: Re: ABS approval
Date: Sat, Apr 25, 1998 18:47 EDT
From: DD531
Message-id: <1998042522474100.SAA13582@ladder03.news.aol.com>
Regarding ABS approval and the delay:
Question: Is there any correlation between the amount of time a 510(k) application is reviewed AND the outcome of that review i.e. approval vs. rejection?
If there is any correlation, it may just be that longer the app. is in the hands of the FDA, the greater the possibility of approval. (assuming no objections have been previously voiced and published by the FDA ....BLUD has no such objections from the FDA to my knowledge)
just a thought...
Subject: Re: ABS approval
Date: Sun, Apr 26, 1998 09:15 EDT
From: ThomasK784
Message-id: <1998042613154200.JAA09188@ladder01.news.aol.com>
DD531,
I spoke to Connie Vinson, IR Director, regarding the ABS2000 approval process. As we all know the ABS2000 is a very unique device. The FDA has no other such units to conduct comparative analysis. Without any prior experience or knowledge the FDA team must rely on specialists in the field to determine the effectiveness of each component. Due to FDA cutbacks there are fewer technicians in the biologic department to review the clinical trials and conduct the necessary tests. Connie stated that the FDA blood unit is very knowledgeable regarding reagents, etc. Reagents and the like are approved much faster. IMHO - Once the ABS2000 is fully understood by these FDA specialists approval will follow. To date, many of the individual processes utilized in the ABS2000 have been approved. IMHO - We are close!
Keep your fingers crossed!
Regards,
Tom |
