FDA Codifies Down-Classification For Devices Such As The Apple Watch ECG App
The agency has codified its over-the-counter ECG software class II classification, which means sponsors can continue to benefit from filing for such apps through the less burdensome 510(k) pathway.
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Software for Google’s Fitbit identifies atrial fibrillation using a photoplethysmography algorithm to detect tiny changes in blood volume with its optical sensor.
US regulators have officially down-classified adjunctive predictive cardiovascular indicator software to class II as part of a trend to make it easier for sponsors to apply for premarket applications.
Agency finalizes order allowing sponsors to submit 510(k) applications for photoplethysmograph analysis software less than a month after doing same for another Apple-led app.