In response to the Covid-19 Public Health Emergency, the U.S. Food and Drug Administration (FDA) permanently exempted seven Class I device types from 510(k) premarket notification requirements. FDA also proposed similar exemptions for 83 Class II devices and one unclassified device.
The seven Class I device types include surgical and examination gloves, whereas the 83 Class II device types include a wide range of products such as home-use ventilators, medical device cleaners, and N95 respirators. Table 6 of the notice provides the full list of the proposed exemptions.
In response to the pandemic, premarket review was temporarily waived on all of these device types due to the sudden, increased need of personal protective equipment and other devices. While the FDA has permanently exempted the seven Class I device types, it is soliciting the public’s views on whether premarket review should be permanently waived for some or all of these 83 device types and views on ways to improve the 510(k) premarket notification program.1
The 510(k) process is both time consuming and expensive. By the FDA permanently exempting these devices from premarket notification, resources can be reallocated towards research and development of other products, as well as allowing these devices to get into the hands of patients more quickly. This also conserves the FDA’s scarce review resources, which have already been stretched thin due to the pandemic.2