Reclassification of Surgical Staplers

by | Jul 19, 2019 | Clinical Trials, FDA, Medical Devices, Pharmaceuticals, Quality Systems, Regulatory, Requirements, Software

FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject to special controls and pre-market notification. Currently, both internal and external surgical staplers are classified as class I, subject to general controls and do not require a pre-market submission. External staplers will remain in class I.

A recent number of the adverse events reported for surgical staplers for internal use has prompted for this proposed rule to up classify the surgical staplers. Stapler malfunction may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs,  and death.1 FDA  reviewed and analyzed  the adverse events reports received via the FDA MedWatch program and observed that the common device malfunctions included malformation of staples, difficulty in firing, misapplied staples, and failure of staplers to fire staples. In studies reporting complications arising from stapler malfunction, bleeding and conversion to open surgery or change of the surgical plan were the most commonly reported consequences, which accounted for almost 10.7% of the 207 reported stapler malfunctions.1

The proposed new classification will require manufacturers of internal use surgical staplers to demonstrate substantial equivalence to a predicate device already on the market. The staplers will also be subjected to special controls to mitigate health risks. FDA believes that as part of the special controls, the following tests can mitigate the risks of device failure, user error, and infection/tissue reaction:1

  • Usability testing
  • Biocompatibility evaluation
  • Performance testing
  • Sterility
  • Shelf-Life

In a Medical Devices Advisory Committee meeting, held on May 30, 2019, panel members unanimously agreed that surgical staplers for internal use should be reclassified as class II with special controls. Additionally, two of the largest surgical stapler manufacturers, Medtronic and Ethicon, agreed that class II is appropriate for surgical staplers for internal use. Industry is expecting FDA to provide affected manufacturers with a clear pathway forward to ensure that access to surgical staplers is not severely impacted. While the reclassification has not yet been finalized, we can expect a draft guidance document for surgical staplers this year and potentially collaborative solutions from industry to prevent user error.

If you have any questions about the new rule, or if you are looking to introduce your device into the US market, please reach out to us at 248-987-4497 or email at

1FDA (May 2019) FDA Executive Summary: Reclassification of Surgical Staplers for Internal Use retrieved on 07/10/2019 from



Song Seto, Ph.D.

Song Seto, Ph.D.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This