FDA will start regulating mobile medical software, according to Director

The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play. Clearly, some apps do play a role in guiding physicians in making diagnoses or making treatment decisions. Others simply provide information that would otherwise be available in textbooks or online.

What the FDA will consider a medical device or not has been an important topic, with many clues that it will consider its provenance broadly, as we have reported previously. As of now, only a few medical apps have been granted FDA approval, including AirStrip and MobileMIM.

According to the medical device consulting firm Emergo, the FDA said conclusively that they will be starting regulatory review of medical apps starting in 2011 at the recent FDA townhall meeting on March 10:

According to information provided by FDA officers at the town hall, software validation will be required for mobile medical applications. Whether such devices would have to go through 510(k) or pre-market approval processes, or be ruled 510(k)-exempt—has not yet been determined, they said.

The regulatory guidelines on mobile medical applications will be offered “later this year”. The statement was attributed to Jeffery Shuren, MD the director of the FDA’s Center for Devices and Radiological Health (CDRH) who led the Town Hall meeting, one a series of meetings held throughout the country to “to engage in a dialogue about issues that are of importance to the public.”

Obviously, this will lead many medical app developers to assess how their products will be be affected and whether their software is classified as a medical device. iMedicalApps will continue to observe this important issue closely.


Felasfa Wodajo, MD

Click to view 5 Comments

5 Responses to FDA will start regulating mobile medical software, according to Director

  1. drrjv March 12, 2011 at 6:58 pm #

    All this will do is raise the cost of medical software and will also most likely make updates arduous as FDA approval will be required. Dumb move in my opinion.

    • Felasfa Wodajo March 12, 2011 at 7:22 pm #

      Those of us who have been affected by interplay between orthopedic implant makers and the FDA know that the effects of fresh regulations are not trivial (ahem).

      There does seem to be, however, an acknowledgement of the importance of speed to medical technology innovation and a new emphasis on transparency at the FDA.

      Let us hope some of these fears dissipate unrealized.

  2. Boomer April 20, 2011 at 5:44 pm #

    Ah yes, Apple will be defendant number 1 or number 2 when the first medical legal case hits. Medtronics trying to be the software leader here better watch out.
    Hey Apple, why do you think Microsoft has been avoiding the medical arena and legally stating no responsibility for operating system and compiler issues? We in the embedded world of devices have been “livin the FDA dream” for many years. It’s amazing we can get product to market with the FDA involved.

    Too bad the FDA drifted from taking out snake oil salesmen and started targeting big money for the government. Legitimate companies that try to obey the ambiguous laws of the FDA get burned. Snake Oil salesmen are still getting away.

    • Felasfa Wodajo April 20, 2011 at 5:50 pm #

      “We in the embedded world of devices have been “livin the FDA dream” for many years.”

      Please tell us more about what you do and why you think this will be different ? We are working on getting more info out on the FDA process and could use more insights.

Leave a Reply