- FDA has finalized the reclassification of surgical staplers for internal use from Class I to Class II, meaning the devices will be subject to special controls and need to undergo premarket review.
- The change, which received broad support from Johnson & Johnson and Medtronic, reflects the large number of medical device reports received about serious injuries and deaths linked to surgical staplers in recent years. The agency also issued final labeling guidance for both surgical staplers and staples to include risks, limitations and specific directions for use of the devices. "These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths," the guidance states.
- FDA revised aspects of the draft proposal in response to feedback from a 2019 panel session and industry, including Medtronic’s 215-page opus, but held firm on multiple points such as the need for a biocompatibility special control.
In 2019, FDA proposed creating separate regulatory requirements for surgical staplers for internal and external use. The proposal was underpinned by the more than 41,000 adverse event reports that FDA received about surgical staplers and staples for internal use from January 2011 to March 2018. The reports included more than 360 deaths. Misfiring and otherwise faulty staplers were implicated in the events.
FDA identified changes to the regulation of surgical staplers for internal use as a way to mitigate the risks of the devices. Industry and a panel of experts voiced broad, early support for FDA’s plans but found fault with aspects of its proposals, leading the agency to spend more than two years finalizing the rule and associated guidance on labeling recommendations.
The resulting documents feature changes proposed by the panel and industry respondents, such as the removal of cancer recurrence as a risk of surgical stapler malfunctions. However, FDA defended and retained other contentious proposals.
Some panelists, as well as J&J, called for "adverse tissue reaction" to be removed from the labeling risks. The removal would have eliminated the need for a special control regarding biocompatibility. FDA continues to see adverse tissue reactions as a risk, though, explaining that the materials come into contact with tissues and can cause reactions unless they are biocompatible.
Manufacturers of surgical staplers now need to meet the special controls on biocompatibility and other aspects of device characteristics and performance. Companies need to submit 510(k) filings, unless they already have clearance, but FDA will hold off on enforcing the requirements for 180 days.
Some companies were already subjecting their devices to more stringent controls before the FDA changed the rules. J&J said its Ethicon unit has historically included both the surgical staplers and the implantable staples in 510(k) filings and listed them together as Class II devices. Similarly, Medtronic said the reclassification is "consistent" with its own practices.
In conjunction with the reclassification, FDA provided recommendations to healthcare providers to reduce the risk of adverse events associated with surgical staplers.