The new article provides additional clarifications for the situations when the patient labeling is not needed, as well as an overview of the requirements for the content of the 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. The document describes in detail the applicable regulatory requirements and also provides recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory framework. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance. 


When Patient Labeling is not Necessary 

Apart from the situations when patient labeling is required, as described in the previous article, the document also outlines the criteria to be applied to identify the situations when medical device labeling is not usually necessary. According to the document, this includes, inter alia, the situations when:

  • A patient will have no opportunity to benefit from the labeling (e.g., when the device in question is just a tool used by a healthcare professional, while the patient is not involved in the decision-making process regarding the use of the device; or the patient cannot provide any information that will be useful for the healthcare professional using the device);
  • A patient’s opportunity to benefit from patient labeling is outweighed by the risk of allowing him the opportunity in an emergency (for instance, in situations when time is of the essence, and the healthcare professional decides to use the device without consulting with the patient first – this applies to all the cases when due to the nature of the situation the patient has no time to familiarize himself with the patient labeling). 


Distribution Methods 

The guidance also describes the approach to be applied by medical device manufacturers when determining the proper way to distribute the medical device labeling. According to the guidance, to increase the chance that the patient labeling would be read by the patient, the manufacturer shall consider the following aspects: 

  • When should the patient labeling be provided?
  • Must an intermediary, such as a health professional or a supplier, pass along the patient labeling or can it be provided directly to the patient?
  • If an intermediary is involved, will there be any logistical difficulties in passing the patient labeling along and can these be overcome? 
  • What are the obstacles to the patient labeling reaching the patient, and what are the solutions to these obstacles? 

The authority also encourages medical device manufacturers to make the medical device patient labeling available on their website to simplify access to the latest version thereof. Apart from that, when determining the most appropriate method of distribution, the manufacturer may also consult with potential users (target audience) to find out their opinion regarding the way the information should be communicated to them. 


Content of Medical Device Patient Labeling: Key Points 

The scope of the guidance also covers the aspects related to the content of medical device patient labeling. In this respect, the authority describes the suggested content and highlights the key points to be taken into consideration by medical device manufacturers to ensure that all the important information is duly communicated to the potential users. The authority suggests the sequence and content of the patient labeling based on the information collected by the authority. As it is stated by the FDA, medical device patient labeling should flow logically in brief, simple, clear language with highlighting to guide the user to the desired information to meet the need at the moment; while the content should be sequenced in a way that is logical for the intended user, with the most important information presented first. According to the recommendations based on the opinion of potential users, similar information should be grouped. 

At the same time, the authority additionally emphasizes that a unified approach cannot be applied in all the cases when the medical device patient labeling is used – the content of the information and the way it is provided may vary significantly depending on the intended users of the device in question and the purpose of the labeling. Moreover, the headings suggested by the FDA are provided as examples, and they can not apply to some of the devices. For instance, in certain cases, the scope of information included in medical device patient labeling would cover only the risk/benefit details, but not the instructions for use. Hence, medical device manufacturers are encouraged to conduct consultations with the groups representing potential users to find out their position concerning the way the information should be provided.

According to the guidance, the information provided to patients should include, inter alia, the following elements:

  • Table of Content (in case the document is lengthy or complex);
  • Glossary (containing the definitions of the most important terms and concepts to assist users in interpreting the information provided);
  • Descriptive information (including the details about the purpose of the device, its description, the description itself, contradictions describing the situations when the device should not be used, risk/benefit information, and also expectations of the device and the procedure associated with the device). 

In summary, the present FDA guidance describes the situations when the medical device patient labeling is not required, and also provides recommendations regarding the content of labeling. The document also explains the approach to be applied when determining the way the labeling should be provided based on the expectations and preferences of intended users. 


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