FDA Reportedly Gearing Up to Regulate Apps

From a no less august source than American Medical News comes a report that the FDA is considering the regulation of medical apps.  See “FDA Signals it Will Regulate Medical Apps“.   The article quotes a source who relayed that at a town hall meeting held in March, the Center for Devices and Radiological Health (CDRH) “plans to issue guidance on mobile medical applications later this year.” (emphasis my own.)

There is no direct quote from anyone at FDA on this, but the report is certainly a surprise, to say the least, to anyone who has followed the agency’s tortuous pathway to the development of some guidance – any guidance – on the Internet and social media.  In October, 1996, the agency held its first public meeting on the regulation of the Internet and the Promotion of Medical Products.  In March 2009, they said it isn’t the medium, its the message.  In November 2009, they did the same 1996 meeting over again, only this time throwing in social media and targeting the end of 2010 for the issuance of a draft guidance.  It didn’t happen.  Then the end of the first quarter for a guidance. It didn’t happen.  Now, they have announced the intention for a study on how the Internet might actually differ from print and broadcast to look at DTC, the Internet and Fair Balance. Given this track record and a time frame that is well into its second decade, you may understandably want to take the news that the agency is going to deal with one of the fastest paced frontiers in new media with a guidance by the end of the year with a grain of salt.  In fact, here is a whole shaker for you.

Timing aside, there is another worrisome aspect to this news.  First, the development of apps has been one of the most innovative developments among new media.  One only has to go to an App Store to see that.  And one only has to download a few to know that there can be vast differences in quality.  Some are great.  Some are duds.  The latter does indicate the need for some oversight to ensure some level of quality when it comes to medical apps.

On the other hand, when it is coming from an agency that has been slow to assess, analyze and respond to emerging media in the past, the rush to push out a guidance on this topic, if true, might be overly ambitious.  At the very least, the agency might seek some public input into the guidance of apps or form an advisory committee for emerging media and technologies.  For one thing is clear – it is in our public interest to ensure that innovation in this promising and burgeoning field isn’t trampled upon by an agency still trying to find its sea legs when it comes to new and developing media.

Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?

Time will tell.  Hopefully.

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3 Responses to FDA Reportedly Gearing Up to Regulate Apps

  1. John Mack says:


    Thanks for posting this. You and your readers may be interested in this recent Pharma Marketing News article: “Pharma SmartPhone/Tablet Apps – Is There a Regulation for That?” In it, I cite at least one pharma app that may be regulated as a medical device if FDA ever notices it!

    Download the article here: http://www.news.pharma-mkting.com/pmn109-article01.htm

    Use discount code ‘APPfree’

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  3. Pingback: FDA Gearing Up to Regulate Smartphone Apps and Social Media? Or Not? | Lab Soft News

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