Pathways' Pick of the Week: Surgical Staplers Scrutiny

FDA completed its planned reclassification of internal surgical staplers from Class I to Class II 510(k)-requiring devices last week, more than two years after it proposed the step and held an advisory panel meeting on the manner. FDA took the step in response to significant adverse events, including deaths, associated with the devices. It was never in doubt that the agency would upclassify the devices, and several large markers of the tools already have 510(k) clearances for their staplers. But there has been deliberation over the exact risks FDA should require on device labeling and other special controls that should be addressed in 510(k) reviews. In its October 7 final reclassification order, FDA declined to remove a biocompatibility testing requirement despite some pushback from the panel and companies. But the agency agreed to remove an “increased risk of cancer recurrence” from the list of complications based on limited evidence. FDA also decided not to include a registry requirement for staplers, even though some panelists called for it. In parallel to the order, the agency released a guidance on labeling recommendations for internal-use staplers and sent a letter to healthcare providers on appropriate use of the devices. The new order also distinguishes internal from external-use staplers, which remain in Class I.

Excerpted from Pathways’ Picks October 13: IVDR Action Anticipated, Stapler Scrutiny, German App Advice, and More,” Market Pathways, October 13, 2021.

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