In a late-December blog post, Food and Drug Administration Commissioner Margaret Hamburg, MD highlighted how FDA’s “oversight and regulation, when done right, can be a key driver of innovation throughout society.”
Describing FDA’s activities on mobile medical apps, Hamburg writes that although many mobile apps pertain to health, FDA “intends to focus its oversight on a very small subset of those mobile apps that are medical devices. We have called that subset ‘mobile medical apps’ and we are approaching their regulatory oversight within a risk-based framework. We believe this approach will promote innovation while protecting patient safety by focusing on those mobile apps that pose greater risk to patients.
“As explained in the final mobile medical application guidance, our regulation of software as a medical device – and a mobile app is software – is based on risk and functionality, and that functionality should be treated the same regardless of the platform on which it is used. For example, an electrocardiography device – an ECG machine – that measures heart rhythms to help doctors diagnose patients is still an ECG machine regardless of whether it is the size of a bread box or the size of a smartphone. The risks it poses to patients and the importance of assuring for practitioners and patients that it is safe and effective are essentially the same.”