The FDA intends to replace the pre-IDE program by the pre-submission program. Pre-Sub will reflect more accurately the difference between all types of submissions (differences for IDE, 510(k), PMA, ...). The draft guidance has just been published.
http://www.fda.gov/MedicalDevices/De.../ucm310375.htm
Another important lesson from this new guidance, is that either the FDA has moved its headquarters to New-Zealand or Kiribati, or they have invented time travel (publishing date of the guidance is July 13th and it is shortly before 2AM on July 13th in those 2 places, but still July 12th anywhere else...)
New FDA guidance: Pre-Submission Program to replace the pre-IDE Program
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