The Food and Drug Administration is finally getting with the program. Bloomberg reports that the federal agency is to launch a trial with tech firms, including Apple, Fitbit, and Verily, to test out pre-certification of health devices. The move would in theory make it easier for such firms to launch new gadgets that could be used to diagnose, monitor, or potentially even manage health conditions. From Bloomberg:
Under the pilot, the FDA will scrutinize digital health companies’ software and will inspect their facilities to ensure they meet quality standards and can adequately track their products once they’re on the market. If they pass the agency’s audits, the companies would be pre-certified and may face a less stringent approval process or not have to go through FDA approval at all.
Gadget makers are fully aware of how powerful wearables could be in health care. Google spinoff Verily is using its own smartwatches to gather huge quantities of data in several new studies. Research has shown that smartwatches could help diagnose heart problems. And Apple even has a secretive gym in which to test its activity monitoring devices.
But while the likes of Apple have long expressed interest in pursuing product development in the area, they’ve also found that the FDA's red tape gets in the way, making the whole process cripplingly slow. The new program may allow them to push gadgets out to the public a little faster.
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