FDA Down-Classifies Another App Linked To Apple Watch
The US regulatory agency has finalized an order allowing sponsors to submit 510(k) applications for photoplethysmograph analysis software. The move comes less than a month after it did the same for another Apple-led app.
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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.
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.
The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.