Surgical Staplers Manufacturers Back FDA Reclassification Bid, But Wary of Special Controls

Published on July 12, 2019 by Sandy Liebhard

Two companies recently voiced approval for aU.S. Food & Drug Administration’s (FDA) proposal to reclassify internal surgical staplers as moderate risk medical devices

However, Medtronic, Inc. and Johnson & Johnson also expressed concern over the agency’s plan to subject the products to so-called “special controls.”

FDA Surgical Stapler Warning

Surgeons use internal surgical staplers to cut tissue, remove organs, and create connections between structures during a variety of thoracic, gynecological, and gastrointestinal procedures.

The instruments are currently categorized as Class I (low risk) devices and do not have to undergo premarket review prior to being sold in the United States. The FDA proposed reclassifying internal surgical staplers as Class II devices earlier this year, after they were cited in more 41,000 individual adverse event reports, including 366 patient deaths, 9,000 serious injuries, and 32,000 malfunctions.

According to the agency, surgical stapler malfunctions can prolong procedures or result in the need for additional interventions, increasing the potential for serious and life-threatening complications, such as:

• Bleeding
• Sepsis
• Fistula formation
• Tearing of internal tissues and organs
• Increased risk of cancer recurrence
• Death

Will 510(K)-Cleared Staplers be Subject to Special Controls

According to a report published earlier this month by Regulatory Review, Medtronic and Johnson & Johnson are onboard with the reclassification. But both companies wanted assurance that products cleared via the FDA’s 510k program would not be subjected to the proposed special controls.

The 510(K) program allows new medical devices to come to market without going through human clinical trials, so long as a manufacturer can show the product is “substantially equivalent” to a device that was already approved via the FDA’s stringent premarket review program.

“We request that FDA provide affirmative confirmation that our products meet these new expectations and if not, grant an expedited presubmission (Q submission) meeting for all impacted manufacturers to discuss the assessment and align on the pathway forward (e.g. letter to file, 510(k) submission),” J&J wrote in comments to the agency.

Medtronic cautioned that requiring a retroactive review of internal surgical staplers already in clinical use could reduce access to the devices.

The company “explained that conducting additional bench and animal testing on devices that have been in clinical use for many years and have an established safety profile is unlikely to provide clinically meaningful information and, in fact, may adversely affect patient access,” according to Regulatory review.