FDA's new guidance on Software Functions and Mobile Medical Applications

The FDA recently issued a new guidance document on its Policy for Device Software Functions and Mobile Medical Applications. This documents supersedes the previous version which was issued in 2015.

What is a Mobile Medical Application?

This is a mobile app that incorporates device software functionality that meets the definition of a medical device and either is intended :

• to be used as an accessory to a regulated medical device; or

• to transform a mobile platform into a regulated device.

 As always, the intended use will determine whether the Mobile App is considered a Medical Device. Don't forget that the intended use can be shown through labeling, claims, advertising, oral or written statements, etc.

 Regulatory Approach

In this policy, there are 2 categories of device software functions:

1. Those that are subject to regulatory oversight

2. And those for which FDA intends to exercise enforcement discretion

Device software functions subject to regulatory oversight

These are software functions that can transform a general-purpose platform into a regulated medical device, regardless of the mechanism behind the transformation.

Examples: 

• An app that provides the ability to control inflation and deflation of a blood pressure cuff through a mobile platform or apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pump directly.

• Software that enables a tablet or similar device, to be used to display results, for example, of a blood glucose strip reader, effectively the tablet becomes a glucose meter.

• Software functions that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy.

Software functions for which the FDA does not intend to enforce requirements under the FD&C Act

The FDA intends to exercise enforcement discretion for software functions that:

1. help patients self-manage their disease or conditions without providing specific treatment or treatment suggestions; or

2. automate simple tasks for health care providers

This is based on the low risk profile of such software functions. 

Examples:

• Software that coachs patients with e.g. obesity or diabetes and promote strategies for maintaining a healthy weight and exercising

• Software that are drug-drug interaction or drug-allergy look-up tools

• Apps specifically intended for medical uses that use a built-in camera for purposes of documenting or transmitting pictures to supplement a verbal discussion in a consultation between a health care provider and a patient.

• Software that calculates Body Mass Index

Regulatory Requirements

All general requirements apply once it's a medical device, including classification.

There are as well 3 possible classifications (I, II, III). More information on specific requirements for the different classes can be found here.

Software functions that are not medical devices

This guidance also gives examples of software functions that are NOT considered to be medical devices:

Just a few from the list:

• Medical dictionaries or encyclopedia

• Question/answer quiz apps

• Surgical training videos

• Portals for educational information

• Apps to analyze insurance claims

• Payment processing apps in health care settings

• General communication apps (email, video, etc) without specific medical purposes

• Apps for meal planning and recipes

• Apps to actively monitor and trend exercise activity

• Apps to help organize and record health information

Conclusion

It's good to see that FDA is providing clearer insight to their position when it comes to Mobile Medical Apps. The document provides many examples and a high level of guidance for manufacturers.