New FDA Guidelines on Medical Device Mobile Apps

Scores of apps are available in the iTunes Store and the Android equivalent that are related to health and well being. This past week FDA issued a guidance (FDA Guidance for Mobile Apps) for Mobile Medical Applications which provides critical and much needed guidelines for industry as to which mobile medical apps are and are not going to be regulated by FDA as a medical device.  Last Thursday the FDA also engaged in a Twitter chat meeting for a question and answer session related to the guidance (#FDAApps).

The 35,000 foot analysis is that if the mobile app fits the statutory definition of a medical device, and if it could pose a risk to patient safety if it does not perform as intended, then FDA approval to market the device is needed.  The device classifications for the apps will be the traditional Class 1, 2 or 3, as appropriate.  However, even if the app fits the definition of a medical device, unless there is a risk of harm, the Agency will exercise “enforcement discretion,” and Agency clearance is not needed.

What about distributers?  The Apple App Store (and the Android and Blackberry – yes we know Blackberry is dying – equivalents) are not considered manufacturers.  The ‘author’ of the software and the developer of the software are considered manufacturers, but it seems that those who simply write the code are not.

What about the details?  The Guidance contains an Appendices generally describing app classifications, and whether the Agency feels that regulatory approval would be needed, or whether enforcement discretion will be exercised.  In addition, theAgency has set up a communication method for a dialogue as to whether an individual app may need clearance or not ([email protected]).

The Guidance provides examples of apps for which enforcement discretion will be exercised:

   Apps that help patients self-manage their disease without providing specific treatment or treatment suggestions;

  Apps affording simple tools to organize and track health information;

  Apps providing easy access to information related to health conditions or treatments;

  Apps helping patients communicate potential medical conditions to health care providers; 

  Apps automating simple tasks for health care providers; or

  Apps enabling patients or providers to interact with health record systems.

The Guidance also offers examples of apps over which regulatory authority will be exercised:

   Mobile apps that are an extension of medical device(s) by a connection for the “purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.”

 “Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.” 

  “Mobile apps that perform “patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations.

Comments made by the FDA during the Twitter chat are instructive, and excerpts follow:

“Most mobile apps currently on the market do not require FDA review”

“The FDA guidance reflects our focused priorities on apps that pose greater risks to patients & is a big de-regulatory action”

“On average, it has taken 67 days for clearance but it depends on the complexity and functionality of the app”

“We will review MobMed in a way that balances risks/benefits w/out creating unnecessary burden for app developer”

“MobMed that require FDA review will be evaluated according the same risk-based system the agency applies to other medical devices”

Given the explosion of apps, and continued technology innovation and development of computer power, and software leveraging that power, this is an important guideline that app developers and medical device manufacturers need to learn and heed.  The tenor of the Twitter chat was that the Agency is in an education phase related to this issue, but it has significant enforcement powers, so the developer and device world will need to be educated quickly.

More information is available, click here.

Tags: , , , ,


Leave a Comment