Wednesday, September 29, 2010 2:52:24 PM
If you looked at the track record of the current FDA review team, you'd see they took 183 days to issue an SE for an x-ray machine. Taking that into account, the DVIS is not the longest device without approval until under the new teamuntil we cross that 183 days which won't be till the second week of October.
Furthermore, KingKong_Guru has shown there can be as many as 8 days of admin time from the date a decision is issued to the letter going out.
Until we hit the middle or end of October, the DVIS is well within the current FDA's pattern for device review.
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