Q: Should the FDA revisit the decision regarding the regulation of medical device apps?
I agree that the FDA should regulate mobile medical apps (MMA) because there is a potential that certain apps used to treat and diagnosis disease states can be harmful to patients when not working properly. When the FDA published the current guidelines for MMAs in September 2013, its intent was to clarify the MMA requirements based on a risk-based approach. Risky device MMAs are monitoring of cardiovascular disease, blood glucose monitoring, and pacemaker adjustments, just to name a few. The clarity toward non-regulated MMAs helps with software development and offers a pathway for FDA review and clearance. I believe FDA’s guidance document is in the best interest of the public health regarding patient safety and efficacy. We certainly do not want apps that are not screened by the FDA on the market that can cause harm. Therefore, these guidance documents and the FDA 510(k) regulations will keep detrimental MMAs off the market.