FDA Device Document Revises Mobile Medical Apps Guidance

July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the regulatory status for these medical devices, but it also makes changes to the draft guidance on mobile medical applications that the agency issued in September 2013 (1400021).

The June 20 draft guidance essentially moves the MDDS category from the apps on which “the agency will focus its enforcement activity into the category of apps where FDA will exercise enforcement discretion,” according to a Regulatory Alert written by Dale Cooke, vice president/group director, Regulatory, Digitas Health LifeBrands.

“FDA has stepped up to effectively enable more personal devices to be unregulated,” said Coalition for Healthcare Communication Executive Director John Kamp. “The revision will serve patients by encouraging competition and speeding innovation. These devices often can be discounted when offered in conjunction with industry support,” he added. “This can be a win-win for both industry and individual health.”

In light of this new draft guidance, Digitas Health LifeBrands recommends that companies take the following actions:

  1. Review existing app development to determine whether the expansion to enforcement discretion applies.
  2. Review enterprise-level app development guidelines, protocols, and best practices to determine what updates are needed in light of the new categorization.
  3. Consider new partnership opportunities with makers of wearable devices for the integration of data.
  4. Consider the integration of data from existing apps that have established application programming interfaces (APIs) for exporting and importing data.
  5. Prepare for the greatly expanded data integration that will be facilitated via Apple’s iOS8, Google Fit, and Samsung’s S Health platforms.

“The FDA’s decision demonstrates its understanding of lowering risk associated with medical device data systems,” Cooke told the Coalition. “Consequently, lowering the regulatory requirements associated with these types of medical devices is a good move and should accelerate the development and adoption of various new mobile platforms for the storage and transmission of patient health information,” he noted. “This is a major step forward in the accelerating trend toward mobile health.”