Attention all budding mobile medical application creators: Just because you can develop a successful healthcare app doesn't mean you're ready to do so. Hospitals often fall into this category, as most developing their own apps are rookies, especially when it comes to FDA-approved manufacturing or development protocol.
"Most of the developers of the thousands of medical apps that exist today for mobile devices are not traditional medical device manufacturers," warns physician and Cerner executive Douglas McNair in a blog post on the company's website. "Few of them have ever 'manufactured' anything before they developed their app. Few of them have any familiarity with FDA regulations. Even fewer have staff who are trained in regulatory submissions and compliance."
FDA legal experts, however, have been clear that ignorance will not protect hospitals that develop their own apps, or even contract to have apps developed for them.
"The days when the regulations [and the costs associated with complying with them] were selectively applied to just a few [large software vendors] are effectively over," McNair continues. "Recent FDA Warning Letters and field inspections show that this is so, every bit as much as the [recent FDA] Guidance document does."
Therefore, it's crucial to get a head start on FDA regulation, McNair says. That means filing now for FDA registration or approval, even if your aren't sure what category to apply under, or which risk class--I, II or III--your app falls into. Your application may not be accepted at this stage, but the idea is to show you're trying comply with the emerging rules.
"The FDA may not have a product-code ready for your app yet, but at least you will have correspondence from the Agency that is evidence of your intention to do what is right," he says.
And this could be more important than you think, as there is a good deal of "gray area" where apps are concerned, McNair indicates.
For example, triage apps that help patients decide if they should go to an emergency room might be considered "reference database look-up" apps, and remain unregulated. But the FDA also could interpret them as being higher risk--and subject to regulation--because their developers market them as counseling patients on whether or not to seek medical attention.
To learn more:
- read McNair's blog post