FDA reclassifies surgical staplers, staples after review links devices to injuries and deaths

Regulatory NewsRegulatory News
| 07 October 2021 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Thursday reclassified surgical staplers and staples for internal use from Class I (general controls) to the more stringent Class II (special controls) after a 2019 review of adverse events linked the devices to reports of hundreds of deaths and thousands of injuries.
With the final reclassification order in place, surgical staplers for internal use must now undergo premarket review and will be subject to special controls before they can be marketed. Alongside the final order, FDA finalized guidance providing labeling recommendations for the devices.
FDA first proposed to reclassify the devices and issued draft guidance on their labeling in April 2019 after its review and reporting by Kaiser Health News highlighted the risks posed by the devices. The agency also convened the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss the increase in adverse events and whether the devices should be reclassified. (RELATED: FDA flags 41,000 adverse event reports linked to surgical staplers, staples, Regulatory Focus 8 March 2019; FDA proposes reclassifying surgical staplers, Regulatory Focus 23 April 2019)
"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," said William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality within the Center for Devices and Radiological Health (CDRH).
Under the final order, FDA is reclassifying surgical staplers for internal use, which were formerly classified as "manual surgical instruments for general use" under product code GAG to Class II, making such devices subject to special controls and premarket review. The order also amends the existing classification for manual surgical instruments for general use to provide a distinction between surgical staplers for internal and external use.
The final order contains several changes from the proposed order based on comments the agency received and feedback from the General and Plastic Surgery Devices Panel meeting in May 2019. Among the changes are the inclusion of four additional risks posed by the devices and the removal of "increased risk of cancer recurrence," and revisions to some of the labeling requirements laid out in the special controls to "provide flexibility for a physician or surgeon to exercise his or her professional judgment."
FDA also said it revised the final guidance in response to comments received on the draft version, including revising the contraindications and warnings section "to avoid being overly prescriptive and not interfere with physicians' decision making under practice of medicine where appropriate," as well as the directions for use and technical characteristics sections.
In addition to the final order and guidance, FDA sent an updated letter to health care providers with recommendations for using surgical staplers and information on reporting adverse events to the agency.
FDA, Reclassification Order, Federal Register Notice, Guidance


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