Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with special controls. The list of devices includes several software as a medical device (SaMD) products.
Between 23 and 30 December 2022, the FDA published half a dozen final orders announcing class II designations for devices and diagnostics products, which means sponsors can apply for those products using the agency’s less burdensome 510(k) pathway. The predicate devices for the products have been allowed on the market through its de novo authorization pathway over the past few of years, and four of the devices are SaMDs. The agency also issued classification orders identifying three devices as class II products during the first week of 2022: brain stimulation programming planning software, implantable post-surgical kinematic measurement knee devices and bone indentation devices…
