Under the implementation of the 21st Century Cures act published in 2016, the US FDA have proposed a list of class II devices (moderate risk) that will be exempt from 510(k) pre-market notification. The agency said that the regulated industry will no longer have to invest time and resources in 510(k) notifications, however the device must still meet other FDA requirements such as quality system regulations.
The proposed list includes 337 product codes (12% of the product codes associated with 510(k) notification. Many of the concerned products are In Vitro medical devices (44% – clinical chemistry, clinical toxicology, haematology or immunology products). The other devices are various products from gastroenterology, urology, cardiovascular, surgical, ophthalmic, obstetrical, otorhinolaryngology and radiology area.
The industry has until 15th May to send comments to the FDA prior to the publication of the list.
The article, list of devices and instructions for submission of comments can be found here.