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Wearables and FDA Loopholes – What are the regulatory standards on health-tracking apps?

Health-tracking and medical services are the recognized “killer apps” for wearables, at least for now. The expensive, lengthy FDA approval process required for medical devices, however, is leading companies, both big and small, to find ways around it.

Regulatory consultant Emergo Group notes that it takes five months for the FDA just to review and clear a device’s 510(k) “pre-market notification” application. Firms must then work with physicians on bench and animal testing. This preclinical stage typically takes two to three years and may cost $10-$20 million before the device is even ready for human testing.

One way around this process is to file for a 510(k) “premarket approval supplement application” after the original 510(k) has been approved. This allows companies to make any number of design changes, and go to market without testing any of those changes on patients. Both St. Jude Medical’s STJ Riata heart defibrillator and Medtronic’s MDT Fidelis wiring leads followed this process, but later had to be recalled because of patient deaths linked to design flaws.

Scanadu recently raised $14.7 million from investors, including Jerry Yang [co-founder of Yahoo! YHOO and Tony Hsie and crowd-funding site Indiegogo, for its disc-shaped personal health scanner that allows the tracking of vital signs, including temperature, blood pressure, oxygenation levels, heart rate, and respiratory rate simply by scanning a forehead. Using its own method to circumvent the FDA, it signed onto a Scripps Translational Science Institute study and notified its crowd-funders that unless they agreed to be part of the trial, their Scanadu wearable device would not ship. The company hinted, however, that the Indiegogo backers could sign to receive their device, and then opt-out of the Scripps trial, effectively getting their Scanadu without FDA approval.

The FDA needs to close these loopholes and streamline the approval process to eliminate the incentive to circumvent the system. While wearables are Class I devices and not as potentially life-threatening as Class III units like implantables, even faulty diagnostic data can cause complications.


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