Thursday November 7, 2013
New rules and regulations will now be requiring the makers of many medical apps to receive FDA approval before offering them to the public. Any medical app that in effect turns a smartphone into a medical diagnosis tool will now be subject to FDA clearance. The mobile health app market is set to reach $26 billion by the year 2017, according to a March 2013 report from Berlin consulting firm Research2Guidance. There are currently about 97,000 mobile health apps available on the market, tapping into a growing desire among consumers to empower themselves and diagnose their own health ailments.
On Sept. 23, the FDA completed regulations related to the level of oversight medical apps will now receive. The vast majority will not require FDA clearance, however apps that turn a smartphone into a regulated medical device will have to be submitted to the agency for review. Businesses that don’t comply will risk having their app banned from being sold in the U.S. This push by the FDA to regulate medical apps is complicated by a gap between the medical regulatory infrastructure and the tech industry.
Pursuing the FDA process for approval can take months or even years, and cost tens of thousands of dollars. Many startups are seeking validation of their projects through crowdfunding campaigns to see if their idea is viable. If public interest is strong and donations robust, this provides the motivation to proceed with the product and endure the FDA process for approval.
Apps that diagnose or treat conditions via smartphones must meet quality standards similar to ultrasound machines, heart stents and other medical devices. A 510(k) application is required — the least stringent of device approval paths — with no clinical trials typically required. However, even just having the regulatory paperwork professionally completed can be costly. The result? A great many helpful medical apps may remain unavailable in the U.S. While some consumers appreciate the measure of vetting and safety that the FDA provides, many businesses are lamenting how difficult it is to get a useful product to a population that loves their smartphones.