Fiercemedicaldevices commented yesterday that Seoul’s Ministry of Food and Drug Safety are pondering if the new Galaxy S5 needs to be subjected to medical device regulation.
The phone is the first smartphone on the market to come equipped with a heart rate monitor; A sensor on the back of the phone near the camera flash that can detect bloodflow beneath the skin.
Similar to North American regulations, South Korean law dictates that any equipment used to diagnose, treat, or prevent diseases must be approved by the Ministry of Food and Drug Safety prior to being marketed. Apparently regardless of the results of their investigation, the device’s launch won’t be delayed. “Even if it is designated as a medical device, the procedure for testing its safety and functions is not complicated,” an unnamed ministry official told Korea’s Yonhap News Agency.
This raises some interesting questions in light of the FDA’s mobile medical app guidance released last year. In the most basic form, I don’t think that a heart rate monitor is a medical device. However, the application of the raw data in a medical context is where I can see things getting caught in regulatory affairs. Of course, Samsung isn’t new to 510(k) applications so I think they should go for it. In a world where mobile health applications are exploding, I think having validated hardware that’s easily accessible to developers could have interesting results. The onus (and regulation) would then fall on the software side of things, for which the FDA has a rather poor track record for approving updates expeditiously….
In the mean time, I’m going to continue learning Java to get in on this mobile app development action.