On Oct. 7, 2021: The U.S. Food and Drug Administration announced several actions related to surgical stapler and staple regulation and safety.
“At the heart of our public health mission is protecting the public by regulating medical devices to ensure they are safe to use,” said William Maisel, M.D., M.P.H., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health. “The increasing reliance on surgical staplers by surgeons to perform more procedures that are minimally invasive, together with the agency’s analysis of adverse events associated with surgical staplers and implantable staples, prompted the FDA to increase regulatory oversight of these devices while continuing to educate health care providers and patients about their benefits and risks. Following our rigorous internal review and input from the public, today’s actions will increase the safe use of surgical staplers and staples as an important alternative to manual suturing.”
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.
“At the heart of our public health mission is protecting the public by regulating medical devices to ensure they are safe to use,” said William Maisel, M.D., M.P.H., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health. “The increasing reliance on surgical staplers by surgeons to perform more procedures that are minimally invasive, together with the agency’s analysis of adverse events associated with surgical staplers and implantable staples, prompted the FDA to increase regulatory oversight of these devices while continuing to educate health care providers and patients about their benefits and risks. Following our rigorous internal review and input from the public, today’s actions will increase the safe use of surgical staplers and staples as an important alternative to manual suturing.”
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.