Mission creep is a worrisome thing – especially at the FDA.
Awhile back there were some folks at CDRH who believed that the mobiles that you hang over a baby’s crib should be classified as a medical device because they can impact vision development.
No – really.
Fortunately, cooler minds prevailed and sanity won the day.
Today, the issue is whether or not some mobile apps can be considered medical devices. It’s important for many reasons, not the least of which is that over-regulation or the threat of FDA action will slow both the development and adoption of mobile technologies for a variety or urgent public health purposes. Adherence and compliance come to mind as well as safety issues relative to appropriate use/safe use.
To that end, an interesting audio interview in the Burrill Report. It's with Joe Smith, chief medical and science officer for the Gary & Mary West Wireless Health Institute about new draft guidance from the FDA on medical apps, how the agency is approaching these products, and whether this provides the clarity needed to promote investment and innovation in this new world of digital health.
The interview can be found here.
This issue, BTW, is yet another reason why the name of CDRH (the Center for Devices and Radiological Health) needs to change to the Center for Medical Technology.
