The US Food and Drug Administration has begun to flex their regulatory muscles with regard to mobile medical devices. For the first time, the FDA sent a letter to a medical app creator inviting them to discuss why their app-based system had not been through the regulatory approval process.
Biosense Technologies Private Ltd. received this letter regarding their uChek system. The system allows patients to perform their own urinalysis at home using their iPhone.
For more details, take a look at our previous article on the uChek system.
The FDA says that their aim is to regulate mobile systems intended to diagnose or treat patients. According to spokeswoman Synim Rivers, “The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don’t work as intended.”
In their letter, they say the Siemens AG and Bayer AG strips used in the uChek system have only been approved for visual analysis. Biosense cofounder Abhishek Sen says they “intend to work very closely with the U.S. FDA in the coming months to ensure that [they] deliver accurate, affordable, and convenient diagnostics across the world.” The uChek system is still available for order on their website and the app is available on the app store.
Biosense is likely to pursue a 510(k) approval as it is the easiest to acquire. The approval only requires the applicant to demonstrate that their device is similar to one already available on the market thereby bypassing the need for clinical trials.
Biosense already claims that the uChek system is “comparable with many commercially available semi-automated urinalysers.”
