Last week South Korea's health regulatory agency, the Ministry of Food and Drug Safety (MFDS), announced that it would review the latest version of Samsung's Galaxy phone -- the S5 -- to determine whether the device, which includes a built-in heart rate sensor -- should be regulated as a medical device. According to a local media report from Yonhap, the agency defines medical devices in a similar way to the US FDA: "equipment used to diagnose, treat or prevent diseases".

A South Korean MFDS official told Yonhap that Samsung would still likely be able to launch the device commercially in mid-April as planned because the procedure for testing the safety of a medical device in that country is "not complicated".

Notably, Samsung already has received FDA 510(k) clearance for its S Health app in the US. The company's app's clearance was designated for a "cardiology signal transmitter", which certainly points to the newest smartphone's built-in heart rate sensor as a potential data source. Of course, the functionality of a device is often not the key to whether or not it needs to be cleared by the FDA in the US -- it's the claims the company makes about the device to the market. It's possible that Samsung's S Health app's clearance is enough for the FDA and the device, which happens to have a heart rate sensor built-in, may not need FDA clearance.

If Samsung sells the smartphone as a device with a heart rate sensor intended for use for fitness use cases, it might not need to pursue an FDA clearance of it. If the company bills the device as part of a system for managing heart disease or other medical issues -- along with its already FDA-cleared S Health app -- it may need to go through another FDA 510(k) clearance.

Samsung's S Health app originally launched for Galaxy S III users in the UK in the summer of 2012. At the time, it received data from Lifescan’s OneTouch UltraMini/UltraEasy Blood Glucose Meter via a USB connection. It also worked with Omron’s blood pressure monitors and one of its body composition scales via Bluetooth, and similar devices from A&D. As MobiHealthNews reported earlier this year, mobile-enabled diabetes management company Glooko is also integrating with Samsung in the US.

That release never found its way to the US. S Health finally launched in the US with the Galaxy S4, but rather than connecting to third party medical devices, it relied on manual entry and purported to connect to three devices from Samsung: a weight scale, a heart rate strap, and a wrist-worn activity tracker. Those devices have still not been made available for purchase in the US, although the weight scale and heart rate strap can be purchased in Samsung's UK store.

“S Health peripherals, specifically the Heart Rate Monitor Band and Connected Weight Scale, will be available before the end of the year,” the company told MobiHealthNews in an email last August. “Samsung is working on perfecting the S Band and will announce when we’re ready for its commercial launch.”