The Food and Drug Administration (FDA) has published a final list that exempts certain class I and class II medical devices from 510(k) premarket review.
The list was completed through authority gained via the 21st Century Cures Act of 2016. As a result of this legislation, the FDA is required to identify low-risk devices which no longer require a 510(k) review for safety and effectiveness.
It is thought that removing the need for 510(k) premarket review will lower the burden on medical device manufacturers and remove any costs associated with keeping up with these rules.
Devices named by the FDA include clinical chemistry and toxicology tests, haematology and pathology devices, immunology and microbiology products as well as anaesthesiology, cardiovascular, dental, and ear, nose and throat devices. Other products on the list are used in gastroenterology and urology, general and plastic surgery, and general hospital and personal use. Devices for neurological, obstetrical and gynaecological, ophthalmic, orthopaedic, physical medicine, and radiology applications are also included.
All devices which are newly exempt from 510(k) review are still subject to other regulatory controls such as good manufacturing practice requirements.