The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to surgical staplers and staples for internal use. The document provides additional recommendations regarding the labeling of these products to be considered by medical device manufacturers and other parties involved. The present guidance constitutes an amended version of the document issued previously by the FDA earlier in April 2019. Due to their legal nature, FDA guidance documents are non-binding, and provisions thereof should not be construed as mandatory requirements to be followed. The Agency also mentions that an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements and has been agreed with the authority in advance. The authority also reserves the right to amend the document, should it be necessary to reflect changes to the applicable legislation.
Table of Contents
Regulatory Background
As it was mentioned before, the present document is intended to provide additional recommendations on labeling for surgical staplers and staples for internal use to address the issues associated with potential misuse that in certain cases could lease to severe negative consequences. The authority expects that recommendations provided therein are necessary to improve the overall safety and effectiveness of such devices by ensuring the labeling contains all important details regarding the way the devices should be used, as well as about the risks associated thereto. However, these recommendations are not obligatory and should be considered in the context of general rules and requirements set forth under existing legislation.
First of all, the Agency outlines the devices covered by the scope of the guidance. As described by the FDA, surgical staplers for internal use are specialized prescription devices used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. As further described in the document, surgical staplers and staples for internal use may be indicated for use in a wide range of surgical applications, including but not limited to gastrointestinal, gynecologic, and thoracic surgery.
The authority explains that the need for additional recommendations is based on the increasing number of incidents associated with medical devices covered by the scope of the guidance. In particular, numerous adverse events reports were received by the FDA about these devices. The Agency has analyzed the information contained in these reports and outlined the most common causes resulting in further complications and other safety-related issues. In some cases, additional surgical intervention could be required to mitigate the consequences. As described by the FDA, this results from both device misuse and malfunctions. The first reason could be a result of unclear instructions for use accompanying the device, or incomplete/inaccurate safety warnings communicated by the manufacturer. Hence, by the virtue of the present guidance, the Agency intends to provide additional recommendations about the safety-related information the labeling for the surgical staplers and staples for internal use should contain to ensure all important information is duly communicated to potential users in a way ensuring it would be interpreted and applied. It is also stated that the recommendations provided therein are in line with the general requirements set forth under 21 CFR 801.109. According to the guidance, FDA believes the inclusion of important device technical characteristics and performance parameters in the labeling would inform end-users on device limitations, thereby increasing the likelihood of appropriate device use and mitigating against device malfunctions, and also recommends that the labeling of surgical staplers and staples for internal use contain the warnings, contradictions, instructions, and usage information identified [in the guidance].
The scope of the guidance covers the devices covered by the product codes GAG, GDW, NLL, and NAY.
Labeling Recommendations – General
As it was mentioned before, correct labeling is important as it could be used to communicate safety-related information to potential users. The Agency has identified that numerous adverse events are caused by misuse resulting from inadequate information provided by medical device manufacturers by the device of labeling, while it is vitally important to ensure all necessary information about the way the device should be used, as well as about the risks associated with such use, should be duly communicated to healthcare professionals and patients. This information should include, inter alia, contradictions, safety-related warnings, directions for use, and also the general parameters and characteristics of the device.
Moreover, the labeling for surgical staplers for internal use should comply with the respective regulatory requirements set forth by regulations 21 CFR 878.4740(b)(2)(ix) and 21 CFR 878.4740(b)(2)(x). The authority has considered the aforementioned requirements when developing the present guidance.
Contradictions
The first important aspect addressed in the guidance relates to contradictions. As described by the FDA, the labeling should clearly outline the situations and conditions when the device should not be used. As prescribed by the applicable legislation, unless data demonstrates the safety of doing so, contradictions must be identified regarding the use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
Warnings
Apart from contradictions, the device labeling should also contain warnings informing users about the most important aspects associated with the use of the device. According to the regulations, unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with the device. The guidance further describes the main hazards associated with the medical devices covered by the scope of the document and provides the appropriate recommendations to be taken into consideration to reflect necessary warnings in the labeling. The document contains examples of device-specific warnings addressing various aspects related to the devices in question.
Directions For Use
The labeling should also contain information describing the particular way the device should be used. In this regard, the applicable regulation states that the labeling should contain specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissues for stapling, as well as validated methods and instructions for reprocessing of any reusable device components. About reprocessing, the document refers to the appropriate guidance document issued earlier by the Agency.
In summary, the present FDA guidance highlights the key points related to the labeling for surgical staplers and staples for internal use. The document outlines the scope of information the labeling should cover, and also clarifies the reasons why this information is needed.
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