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gophilipgo

08/21/09 11:37 AM

#4210 RE: Pitbulls #4209

The FDA is late with medical device decisions as well. Look at NEPH.
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nomonet

08/21/09 4:02 PM

#4222 RE: Pitbulls #4209

Most often it depends on the type of devices and type of submission. Also it depends on the clinical data and the regulatory group putting the data together that has a bearing.
Typically on simple devices is ranges from my experience 3-6 months depending on the FDA questions. You always get questions back.

To add prospective.....here is a Reuter's link that might help.

http://www.reuters.com/article/healthNews/idUSWBT00924520080623