FDA Updates Mobile Apps Guidance DHLB Regulatory Alert Available

Updated to correct important error: Correcting "not" to "now" in opening paragraph.

On Friday, CDRH came out with a new guidance that included revisions to the previously finalized guidance from September 2013 about mobile medical apps. The most significant aspect of this guidance is that systems that simply transfer medical imagery and data from one platform to another will now face a significantly lower regulatory burden.

You can read the Digitas Health LifeBrands Regulatory Alert about this guidance here.

In many ways, this activity was foreshadowed by the update made earlier this week to the list of mobile apps that would receive enforcement discretion.

On a tangential note, the recent activity from CDRH on this topic is welcome because, in my view, it correctly demonstrates a willingness to update FDA's position as new information is released, but it does present some challenges for industry and some problems with the existing Good Guidance Practices, and FDA is clearly aware of some of these difficulties.

According to GGP, Guidances must be released in draft status with an initial period of comment of at least 90 days. Then, FDA has the option of finalizing the guidance unaltered, updating the guidance and releasing a revised draft, updating the guidance and releasing a final version, or doing nothing (in which case the guidance stays in draft status).

What we have in this case is FDA proposing a new draft guidance with edits to a previously finalized draft guidance, and at least as of today, there's nothing in that finalized guidance to indicate to readers that it no longer represents FDA's current position. I understand the desire to not retract a final guidance or change it back into a draft guidance for every update, but in this case, someone could easily read the final guidance and not realize that it is outdated.

It seems the far better practice is what CDRH is actually adopting, namely, maintaining a webpage that is more easily updated that a formal guidance document, but the status of the webpage versus the guidance documents themselves seems to create some tension.

Perhaps moving forward, FDA should limit the guidance documents themselves (because of the time-consuming process needed to update them) to the principles FDA is applying with more easily updated lists referred to in the guidances themselves.

Of course, if FDA's view about the regulatory status of a product, device, etc., is subject to revision too frequently, then clearly there's a deeper issue that needs to be addressed.

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