Posted by Michael Wonder on 07 Oct 2021
FDA issues final order and guidance on surgical staplers and staples for internal use
7 October 2021 - Today, the U.S. FDA announced several actions related to surgical stapler and staple regulation and safety.
The agency issued a final order reclassifying surgical staplers for internal use from Class I (general controls) to Class II (special controls) and requiring them to undergo premarket review.
As a result, surgical staplers for internal use will be subject to more stringent regulatory requirements, including requiring premarket notification and special controls to help mitigate known risks of the device.
