FDA Issues Draft List of Class II Devices Exempt From Premarket Notification Requirements
The Food and Drug Administration recently asked for comments on a proposed list (here) of class II medical devices that will be exempt from premarket notification requirements once the list is finalized. The 21st Century Cures Act, enacted in December,…
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
requires FDA to publish the final list by 210 days after enactment and then every five years. Comments on the draft list are due May 15.