Recently, an online discussion board broached the subject of FDA approval for a diagnostic app that might be able to predict when a patient’s condition would relapse. The question postulated whether there was a way to circumvent FDA approval by launching the app in another country and making it available online. And, if the app was launched from another country, would it require regulatory approval in the country where purchased?
The discussion ran to nearly 150 comments and was, at times, curious, cautious, and thought provoking. Some dismissed the idea outright as terrible; others said they needed more information to form an opinion. Still others felt this warranted a deeper discussion on motives.
A lot of the discussion centered on the risks vs. reward. Is a disclaimer (even in bold print) enough to cover legal issues, should they arise? Can you control which users would be excluded from downloading the app, provided their country required its own regulatory approval? Does the app actually require FDA approval, or would it even be excluded because it is not intended in any way to treat the user? Would the app developer’s insurer cover any lawsuits resulting from use of the product? Would it need to comply with local regulations in every country where it could be downloaded? What if there as no cost? How quickly can the FDA adapt to policing new technology? One comment even placed the safety onus on the buyer saying caveat emptor.
One regulatory affairs specialist weighed in with these thoughts: even if the software is available for free (no profit), it could still be subject to regulations and bypassing regulatory compliance promotes an “uneven playing field” for device manufacturers.
The best advice was a referral to this FDA link .
According to the FDA, judging by “industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.”
In September 2013, the FDA issued its Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff explaining the agency’s oversight as being focused only on apps that present great risk to patients “if they don’t work as intended,” as well as on apps that cause smartphones “to impact the functionality or performance of traditional medical devices.”
In fact, the FDA does have a goodly amount of information readily available online about which types of apps it needs to weigh in on and which types do not require oversight from that agency, with specific examples. In case of doubt, the agency encourages you to contact
