FDA Allows 510(k)s For HIV Diagnostics
The tests are being moved to class II, special controls, after the agency determined that would be enough to ensure device safety and efficacy.
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Regulators say that despite millions of HIV viral load monitoring tests on the market over the past 25 years, there has only been on class II recall for the products, which warrants easing their path to market.
For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component
Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.
US regulators plan to hold a public meeting later this year to address concerns the devices are less accurate for people with darker skin tones.