In July 2011 the FDA released draft guidance on mobile medical applications that indicates which mobile medical apps fall under medical device regulatory requirements, and which do not. Although not all types of mobile medical apps are covered by the guidance, the FDA’s proposed rules show that the agency will not be taking a one-size-fits-all approach to these applications. In my opinion the draft guidance uses a sensible pragmatic approach. The FDA will consider the application a medical device if any of the following are true:
- The app is a component of a medical device
- The app is an accessory to a medical device
- The app is intended for use in the diagnosis, treatment, mitigation or prevention of a disease
But this still leaves some grey areas which require clarification. For example, do apps intended for patient self-management or simple apps for tracking or showing trend data (not intended for treating or adjusting medication) require approval? I hope to see the formally released guidance provide further clarification of this. Maybe the FDA will state this is discretionary and leave it for the developer to determine if regulation is required.
As a designer I can see many new and innovative opportunities for medical device applications to improve healthcare through standalone apps or as additions to medical devices and I look forward to being involved with and watching this sector develop. Given that the mobile medical application market has only just begun to take off let’s hope that regulators can keep up with this fast changing sector and successfully regulate without stifling innovation and progress.
Examples of mobile medical applications cleared by the FDA:
Sanofi iBGStar blood glucose meter:
MobiSante Portable ultrasound:
MIM Software Radiological image processing:
Airstrip Technologies Remote patient ECG monitoring:
