A Notice was published in the Federal Register the 15th January 2021, about the exemption of a long list of medical devices from premarket notification. This list, found in table 6 of the Notice, contains 83 class II devices.
Yet, we have to wait for 120 days, to see this Notice published with the list in its final version.
Friday 5 February 2021
FDA about to exempt fifteen software devices from 510k clearance
By Mitch on Friday 5 February 2021, 12:40 - Regulations