iMedicalApps has an interesting Q&A today with Mark Cain, chief technology officer of MIM Software, a developer iOS radiology applications (we've written about MIM before on Scope). If you're interested in medical app development, the whole entry is worth reading, but I found the question on the FDA approval process most interesting:
What did it take to get FDA approval?
We submitted it in July 2008. Within one week, there were a lot of questions and a lot of confusion. The FDA was confused because it sounded like a hardware device, not software. Also, the fact that we were submitting workstation-type software for a “phone” increased the confusion.
FDA clearance was finally granted on Feb. 4, 2011. The rest of the process is worth reading about.