Published by
Stanford Medicine

FDA, Medical Apps, Technology

A look at the FDA approval process for an iOS radiology app

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.

Previously: FDA approves first diagnostic radiology application for mobile devices and FDA to release guidance for mobile health apps this year

2 Responses to “ A look at the FDA approval process for an iOS radiology app ”

  1. Mark Cain Says:

    Since you mention that section, here is a little more detail.

    We had always done software 510(k) submissions. We treated this submission the same way. After all, we didn’t manufacture the iPhones. However, the fact that our software ran specifically on these devices created the new problem. How do we clearly explain our software only product in the context of specific hardware? This took some time to iron out, obviously, but we eventually got to the point where we satisfactorily addressed the off-the-shelf nature of the hardware.

    Thanks for mentioning the article.

  2. John Stafford Says:

    Mark, thanks so much for the additional information. I thought the process was quite interesting given the emergence of this platform.


Please read our comments policy before posting

Stanford Medicine Resources: