The new article describes in detail the applicable regulatory requirements related to the descriptive information to be included in 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 – special labeling containing information addressed to patients. In particular, the document outlines the scope of information to be communicated to patients and describes the approach to be applied when determining the particular way such information should be provided. It is also important to mention that the guidance is non-binding in its legal nature, and is not intended to introduce new rules or impose new obligations, but to provide additional clarifications concerning applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto.
The scope of the guidance covers, inter alia, the aspects related to the descriptive information to be included in medical device patient labeling. The authority highlights the key points to be addressed, and also provides additional clarifications to be considered in this respect.
Purpose and Description
First of all, a descriptive part of labeling should include a brief description of the intended purpose of the device, including the indications for use cleared or approved by the authority. Apart from this, the manufacturer should also provide a brief description of the product itself, its components, and accessories thereto. Usually, pictures and drawings could be used to provide such information in a way making it easier for patients to understand it. Such drawings should demonstrate all the key components of the device, while the test part of the description should provide details about the functions and purpose of all the components. Apart from this, medical device manufacturers are also encouraged to provide a list of materials used so that patients with hypersensitivities will be aware of potential risks.
To ensure the safety and proper performance of the device, the manufacturer should also provide information about contraindications to be considered by patients or other persons using the device. This includes a description of situations when the device should not be used. According to the guidance, contraindications stand for conditions under which the device should not be used because the risk of use outweighs any possible benefit. For instance, the device should not be used by persons with a specific health condition – e.g., pregnant women. In this section, the manufacturer should describe in detail reasonably foreseeable hazards, and also outline the aspects for which there is no sufficient information.
As further explained by the FDA, contraindications to the use of a device could include:
- Demonstrated hypersensitivity to a material where there is patient contact with the device,
- Substantial risk of being harmed because of patient characteristics (e.g., age, gender, accompanying therapy, disease state, health status), or
- Continued use in the face of an unacceptably hazardous adverse event.
Risks and Benefits
Apart from the aspects described hereinabove, the information communicated to patients should address the matters related to risks and benefits associated with the device. In particular, the manufacturer shall duly provide all the information the patient will reasonably need to be able to make an informed decision, provided he fully understands the effects. Usually, such a decision-making process is based on the evaluation of information related to risks and benefits associated with the device when used for its intended purpose to determine whether the benefits outweigh the risks. The scope of information to be communicated depends on the particular device and, consequently, should be determined on a case-by-case basis, provided that the factors related to the target audience (potential users) are duly considered as well.
According to the guidance, the goal of risk/benefit information as applied to medical device patient labeling is to provide the patient with information about the risks and benefits associated with a device or procedure in a manner that is meaningful to the user. As it is further explained, risks and benefits conveyed in an effective and meaningful way to the user should aid the user in deciding whether to use a device, or undergo a procedure that uses a device, and motivate the user to use the device as labeled.
The document also provides a list of key points to be considered concerning the inclusion of risk/benefit information in medical device patient labeling. This list includes, inter alia, the following recommendations:
- When developing a patient labeling, the manufacturer should take into consideration the concerns potential users may have for the device in question;
- Wordings are vitally important, as they impact the perception of the information provided;
- The patients should be duly informed about the actions to be taken to avoid the risks associated with the use of the device for its intended purpose;
- All the risks and benefits should be described as clear and precise as possible;
- The information about risks and benefits should be provided in the same balanced way to avoid patients being influenced by the way the information is provided;
- Use visual materials (pictures and drawings) to assist patients in interpreting the information related to the device and the risks associated thereto.
The authority additionally describes the suggested content of a risk-related message. In particular, such a message should:
- Describe specific actions to be taken to mitigate the risks or at least obtain additional information;
- Not use terms that are unclear or unfamiliar to potential users of the device;
- Provide patients with reliable and unbiased information, without the intent to affect the decisions they make.
In summary, the present FDA guidance describes in detail the approach to be applied when providing descriptive information to be included in medical device patient labeling. The authority highlights the key points to be considered to ensure the patients are duly informed about the risks and benefits associated with the use of the device.
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