Third in Series: FDA Draft Guidance – Mobile Medical Apps: There’s a Tweet For That

August 10, 2011

On Tuesday, July 19, following issuance of its highly-anticipated draft guidance on mobile medical applications, FDA held a Twitter chat at!/FDADeviceInfo, #fdaapps, to elucidate on its thinking and provide further insight into interpreting its position on regulating mobile medical apps.

Here is a brief summary of the most salient interpretive tweets by Bakul Patel, FDA policy adviser and author of the guidelines:

Device Applications That Will Be Regulated

  • FDA tweeted that the guidance was targeted only to a small set of applications that are “used as an accessory to med device . . ..” Examples of these applications given by FDA included an application that allows a provider to view medical images to make diagnosis and applications that turn an iPad into an electrocardiogram.

Device Applications That Will Not be Regulated

  • Any applications that are meant to monitor health and wellness will not be considered a mobile medical application.
  • Applications that store medical records or provide training videos to physicians.
  • Personal health records.
  • Mobile computing devices and smartphones in and of themselves will not be regulated, but FDA will be regulating some applications that would be available on these devices.

Regulatory Strategy

  • FDA noted that it will be collaborating with the Office of the National Coordinator for Health and individual user’s adverse event reports and feedback, in regulating mobile medical applications.
  • Regulation of applications will be risk-based, so that applications that have the most potential for harm will face the strictest regulation.

Foreign Apps

  • For foreign-developed applications, FDA tweeted that it would regulate such applications that qualify as mobile medical applications, if they are distributed in the United States.

FDA’s draft guidance is open for public comment until October 19.

McGuireWoods has extensive experience as counsel to a broad range of life sciences companies. For more information on this topic, or for guidance to help ensure compliance, please contact us.