I'm using the word "new" in the headline of this blog post in the technical sense that FDA uses for promoting drugs, namely within the past six months, because the new guidance was actually published in February of this year. I didn't notice it at the time, so apologies for the late notice.
I'm blogging about it anyway because the topic is of interest in general (namely what apps are subject to FDA enforcement focus vs. enforcement discretion), and because the update itself is interesting to FDA process geeks like me.
Here's a quick timeline for the uninitiated:
In 2011, FDA released its first draft guidance* about how it would apply its regulatory authority to the realm of mobile apps. Here's my take at the time.
Industry (and Congress) reacted as if FDA were suddenly imposing a new set of regulations on a vibrant and rapidly evolving technology, despite the fact that FDA had been regulating apps for years.** As a result, there was significant pressure exerted on FDA to finalize its guidance.
In 2013, FDA released a finalized version of the guidance. Here's my take at the time.
In 2014, FDA released a new draft guidance about Medical Device Data Systems. As I noted at the time, this guidance significantly downgraded the regulatory status of MDDS, essentially shifting the entire category of apps from the group of apps where FDA would focus its regulatory attention to the group of apps where FDA would exercise "regulatory discretion," i.e., choose not to enforce regulatory requirements.
In addition, this guidance also by extension altered the finalized mobile apps guidance, and though I agreed (and continue to agree) with this decision, I mentioned that this created an odd situation for those relying on FDA's guidance. We had a new draft guidance about MDDS, which was making revisions to the mobile apps guidance, without any indication in the mobile apps guidance itself that it was undergoing a revision.
Instead, FDA is maintaining a separate, real-time listing of apps that it is updating as individual classification decisions are being made.
I applaud this innovation. I think it helps industry tremendously to have FDA maintaining this consolidated listing of decisions, especially because (as the MDDS guidance itself shows), FDA is willing to reconsider these decisions as the technology evolves.
The wrinkle is that you have to keep on top of these process issues closely to understand them. Otherwise, you'd find yourself going to the guidance, which was always kept in its final status, and assume that you were reading FDA's current thinking about a topic without realizing that FDA had released other, newer guidance that contradicted the position from the "final" guidance.
Well, as of February of this year, that discrepancy has been resolved. FDA finalized the MDDS guidance, and at the same time (apparently), released an updated final mobile apps guidance.
In reading through the new version of the final guidance, it does not appear any significant changes have been made to the FDA's classification scheme for mobile apps, or any additional reclassifications have been introduced; however, if anyone finds such changes, please point them out in the comments.
* I'm posting this (and other) guidance on my own site. My sharing these documents should not be construed as endorsing the views set forth in it, nor should it be taken as a sign that these views represent FDA's current position. This link is merely being provided for historical research purposes and use by others who would like to see how FDA's position has evolved.
**According to both FDA and press, FDA has been clearing (i.e., regulating and accepting apps as medical devices) since at least 1997.
Showing posts with label apps. Show all posts
Showing posts with label apps. Show all posts
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.
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.
Busy Week in Rockville (and Philadelphia)
CDRH has released a new draft guidance about mobile medical apps. Here it is.
I'm reading now and will have more later.
I'm reading now and will have more later.
FDA will not regulate Apple's HealthKit
In case you missed it, FDA has been updating its list of mobile apps where it intends to exercise enforcement discretion (on that concept in the FDA guidance on mobile apps see here and here). MobiHealthNews has a more extensive story here.
The most significant fact is that FDA has apparently added a new category that seems designed explicitly to include Apple's new HealthKit that was announced on the WWDC a few weeks ago.
h/t @wapgeekboy
The most significant fact is that FDA has apparently added a new category that seems designed explicitly to include Apple's new HealthKit that was announced on the WWDC a few weeks ago.
h/t @wapgeekboy
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