Medical Mobile App Clearance Times Decrease

by Holly Shoemaker

The Emergo Group, a medical device consulting firm, has provided updated information that shows the time it takes for apps that undergo the 510(k) process has decreased.

Numbers at a Glance

The study shows that medical mobile apps that undergo the 510(k) process takes about 138 days to receive clearance from the Federal Food and Drug Administration (FDA) in 2011, which was down from 146 days in 2010.

The data analysis took submissions through the end of 2011 to look at a 12-month data set. The analysis showed that 95 to 97 percent of all 510(k) applications received FDA clearance within one year of submission.

What is 510(k)?

The 510(k) status is a pre-market submission made to the FDA to show that a device may be marketed as safe and effective. Introducing a new device or changing the usage are some reasons for needing this clearance. The FDA publishes further guidelines here.

Good News for Developers 

One of the hurdles for developers designing medical mobile apps was the time needed for clearance. Any additional delay meant using more time, money and other resources. What the study found was that many medical mobile apps have a shorter wait time for clearance when compared to other devices.

Another study by MobiHealth News found 76 cleared apps in the FDA’s 510(k) database, and the average clearance time was less than the time reported by Emergo Group. This study found the clearance time was 25 days shorter between 1997 and 2012, with an average time of 110 days.

Outstanding Issue

Developers continue to debate what the time for clearance actually means. The FDA’s data defines the dates as when the agency receives the 510(k) application and the official “decision date.” Some developers and companies say the wait for clearance is longer because discussions occur before the actual filing of the application.

While medical mobile apps requiring FDA clearance takes more planning, developers have many tools to assist them. I still recommend using Happtique guidelines to assist, as that app store dedicates itself to just health apps.

Concluding Thoughts

No matter which study patients believe has more validity, both show progress when it comes to medical mobile apps clearance. That is untimely good news for patients too because they gain access to better quality information. Once approved, the device is deemed safe and effective, which helps marketing efforts and branding.