In a new poll, 68% of physicians, healthcare professionals, medical app developers, and members of the general public voted that the FDA should regulate medical apps. You can see the results and a discussion of the poll online at The Profitable Practice blog.
For app developers, the key point to keep in mind is that FDA is only planning to regulate software apps that will “transform a mobile device into a medical device already regulated by the FDA” or that can be used “as an accessory to a medical device.” This is in line with the common sense approach taken by a number of EU member states such as Sweden.
Back in a March posting Should FDA Regulate Medical Apps?, I noted that the vast majority of so-called “medical apps” or “health apps” are really geared for the general public and layman to provide basic medical or health information. Trying to regulate these 17,000+ apps would bring FDA to its knees even if all of its personnel were magically transformed into medical app expert reviewers. This point was taken up and agreed to by FDA’s Baku Patel, as I pointed out in a July posting, Majority of Mobile Health Apps Class II Devices for FDA.
Now, with the release of FDA’s final guidance on medical apps, FDA has stepped back from the precipice and taken the more common sense approach advocated by this blog, the EU, and by the many, many critics of FDA’s initial draft guidance on mobile health apps. FDA’s regulatory focus is on apps that – if they malfunction – have a direct risk of harming the patient.
With this approach, FDA will not inadvertently treat the Apple, or Google, or Amazon’s app stores as distributors or pharmacies. This was another minefield in the initial draft guidance that is now resolved.
That said, Apple has formally implemented a policy for new medical and health apps on its app store wherein developers need to provide specific medical citations and sources for any medical information contained in an app. This is no different than how medical journal articles must cite sources. Read more about Apple’s new policy on health app medical source requirements.
Download the final FDA mobile medical app guidance
Read more about the poll conducted by medical software resource Software Advice
List of 21 types of health apps that FDA will not regulate.