The new article provides the details regarding the troubleshooting information to be included in medical device patient labeling.
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 medical device patient labeling – a special type of labeling intended to communicate important device-related information to patients or laypersons using the device. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, neither is intended to introduce new rules or impose new obligations apart from the ones prescribed by the underlying regulations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to the troubleshooting information to be included in medical device patient labeling to ensure the devices are used safely and efficiently for their intended purpose. In this respect, the authority encourages medical device manufacturers to provide troubleshooting information in a separate section which should be easy for potential users to find. In general, users refer to troubleshooting information in the case an issue occurs and they are searching for a way to resolve it. Thus, the manufacturer should describe the reasonably foreseeable issues users may face for the setup, operation, and maintenance of a medical device in question, and then suggest solutions for such issues. It is also stated that similar problems could be described as groups, while it is important to ensure the ease of navigation inside the group when searching for a resolution of a specific problem. The authority also mentions that the issues that could be life-threatening should be described at the very beginning of each section. The whole section should be provided in a way allowing users to navigate it easily and find a resolution without undue delay. For instance, the troubleshooting section could be a table with a column for signs of trouble and a column for actions.
As further explained by the FDA, the manufacturer should provide a clear and understandable description of each issue – such description should be quite short to ensure that the users who have no special qualifications will be able to interpret it accurately. After this, a step-by-step description of the actions to be taken should be provided. The authority additionally emphasizes the importance of ensuring that users would not be confused by numerous terms used in the description of an issue or steps to be taken.
At the same time, in case of some issues that cannot be resolved by a user himself/herself, the appropriate warning should be included. Moreover, should it appear that the issue faced by a user is not described in medical device patient labeling, it should be a clear instruction to contact healthcare providers and ask for assistance. The authority also mentions that assistance-related information provided in this section does not substitute similar information to be provided separately in the respective section.
The users should also be explained how they should report incidents and adverse events that may occur during the use of a medical device.
The guidance also outlines the scope of additional information to be included in medical device patient labeling to ensure the users are duly informed about all the important aspects to be considered when using the device for its intended purpose. For instance, this includes the details on adverse events or clinical studies. As explained by the FDA, the manufacturer should determine whether such information is to be included in the medical device patient labeling depending on the target audience of the product in question. Thus, the manufacturer may either include such additional details in patient labeling or just mention that some additional details could be provided upon request – in such a case, contact details should be provided. According to the results of special testing conducted by the authority, most potential medical device users prefer to be able to choose whether they will read additional information or not.
For additional information that could be included in medical device patient labeling, the authority highlights the following key points:
- Information related to clinical studies. If provided to the patients, the information related to clinical studies should be described simply and understandably.
- Disease and self-care information. In certain cases, it makes sense to provide such information, but the final decision should be based on the target audience.
- Adverse events. As explained by the FDA, devices whose applications are supported by clinical trials will have data about adverse events that occurred during these trials and that may be of value to the device user; while other devices may have adverse event data from other sources, e.g., published literature or experience with similar devices. When deciding on the specific aspects to be addressed when describing adverse events, the manufacturer should consider the way potential users will benefit from such information. In case the device in question is to be placed on the market under the Premarket Notification pathway meaning that there is no information about adverse events in place, the manufacturer may provide general information about potential adverse events that may take place when the device is used for its intended purpose.
In summary, the present FDA guidance describes in detail the information to be included in medical device patient labeling for various use-related matters. The authority also explains the way such information should be provided to ensure it will be interpreted correctly – this becomes especially important since patient labeling is addressed to laypersons who have no special knowledge or qualification.
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