With the unprecedented COVID-19 public health emergency leading to an unforeseen demand for certain medical devices, the US Food and Drug Administration (FDA) has published a notice exempting these devices from 510(k) premarket review requirements.
The seven class I devices (all of which are either surgical or patient examination gloves) had already been subject to a temporary waiving of the premarket review requirements, however now these devices are permanently exempted from this 510(k) requirement. This exemption has taken effect from the publishing date of the notice which was 15 January 2021.
Additionally, the FDA have detailed a proposed plan to permanently exempt a further 83 class II devices and one unclassified device. These planned exemptions cover a range of devices also in high demand during the pandemic such as N95 respirators, home use ventilators and medical device cleaners (to name but a few). The agency is making this proposal based on the lack of any adverse event reports for both the unclassified and class II devices. For a period of sixty days, the proposal is open to the public for comments and responses.
This regulatory flexibility is one way the FDA is hoping to tackle the COVID-19 pandemic. As well as providing more efficient public access to these devices due to fewer regulatory obstacles, it also benefits the FDA as the agency can focus its resources on other regulatory areas that would benefit the public health response.
To view the notice in full, click here.