FDA and the Mobile Med Device Movement

With med device application downloads to smartphones, such as iOncolex and CPR Training, and medical school PDA requirements, FDA compliance has got to be on the forefront. So will they be putting their foot down any time soon on compliance regulations of these mobile apps? And how does this affect the developers of medical devices or even the garage-developer/inventor?

According to MedGadget there are already thousands of apps that have been created for the medical device world. The dilemma on whether the FDA will begin requiring that all applications go through a clearance process is becoming an issue.

It’s important to understand what is considered a “medical device“. In mobile health technology an accessory or a component of a medical device is considered to be regulated as a medical device. Software can even be a medical device is it’s written on computer media versus printed on paper.

It’s a very interesting subject and one that you will see more of on our blog as new advances come out.