Additional Class II device exemptions targeted
In addition, the agency has proposed permanent exemptions from 510(k) registration requirements for 83 Class II devices (as well as one unclassified device); a lack of adverse event report data on these devices led FDA to deem premarket notification unnecessary. The regulator had opened a 60-day comment period on these proposed further exemptions.
Types of devices targeted by the permanent 510(k) exemption proposal include a wide range of products and systems: home-use ventilators, airway monitoring systems, OTC electrocardiograph software, air purifiers and cleaners, medical device cleaners, N95 respirators and oxygenators. Table 6 of the FDA notice provides a full list of Class II and unclassified devices identified for exemption.
As well as supporting increased public access to devices needed during the coronavirus pandemic, these new and proposed 510(k) exemptions would allow FDA to dedicate regulatory review resources to more mission-critical areas, including towards devices and technologies to combat COVID-19.
Related COVID-19 and US FDA medical device regulatory resources:
- COVID-19 regulatory news and analysis resource center
- US FDA 510(k) consulting for medical device and IVD companies
- FDA Emergency Use Authorization (EUA) support for medical device and IVD manufacturers
- Webinar: FDA EUA for medical devices and IVDs