Perhaps more than any other metric, the time it takes to secure clearance is the one that gets the most attention for 510(k) devices. An updated analysis from medical device quality assurance and regulatory consultants, The Emergo Group, finds that the average time it took for a medical device to complete the 510(k) process was about 138 days in 2011, down from 146 days in 2010. The company determined those averages by analyzing the times for thousands of devices that completed the process those years.
Many mobile medical app developers cite the time to clearance as a significant barrier, but compared to the overall average time to clearance for all medical devices, mobile medical app device makers have a shorter wait.
In a recent study MobiHealthNews found 76 cleared mobile medical apps in the FDA’s 510(k) database, and the average time to clearance for devices that had a mobile component was considerably less than the overall average that Emergo Group found. The average time to secure clearance for mobile medical apps is shorter by 25 days and for these devices, which were cleared between 1997 and 2012, the average time it took was 110 days, based on MobiHealthNews’ data.
For the 75 FDA Regulated Mobile Medical Apps report, MobiHealthNews used the FDA’s own definition of a mobile medical app to determine which cleared medical devices to include. The FDA laid out its definition in late 2011 when it published its draft guidelines for how it should regulate medical apps moving forward.
Of course, this “time to clearance” data is based on the dates provided by the FDA for the date the agency officially received the 510(k) application and the date the FDA described as its “decision date”. However, some companies have described their actual time to clearance as being much longer since discussions that occur before the official application is filed are not counted.
For example, Proteus Digital Health and MIM Software worked with the FDA for years to gain 510(k) clearance. Proteus offers an ingestible sensor, wearable vital sign monitoring patch, and companion smartphone app. Proteus first sought FDA clearance for both the ingestible sensor and the patch in 2008, but didn’t get clearance for the ingestible sensor until mid-2012. MIM Software had a well-documented, frustrating experience with the FDA. It received a lot of publicity in 2008 as it was one of the only medical apps to give an on-stage demo at the Apple Worldwide Developer Conference that launched the AppStore, but a few months later MIM Mobile was taken out of the AppStore and told by the FDA that it needed to seek a 510(k). It wasn’t until early 2011 that it received FDA clearance — and the FDA made a big deal out of the app’s 510(k).
The Emergo analysis shows that between 95 percent and 97 percent of all cleared 510(k) submissions occur within one year of submission. The firm also found that half of all medical devices submitted for FDA 510(k) clearance fall under orthopedic, cardiovascular, general and plastic surgery, or radiology categories. Radiology devices generally have the shortest review periods, while chemistry-related devices like blood glucose testing systems take the longest – about 180 days on average.