FDA has released draft guidance that outlines the requirements for premarket notification submissions of non-resorbable plates, screws and washer devices for bone fixation.
According to FDA, this draft guidance will only apply to non-resorbable, nonspinal class II bone plate and screw system, stand-alone bone screws, and associated washers. These devices are safe and effective, FDA stated. FDA said that the guidance will help to ensure consistency in submissions and address common issues related to device descriptions.
