The new article describes in detail the aspects related to pretesting in the context of 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 specific type of labeling intended to communicate vitally important information directly to the users of medical devices, who are laypersons having no formal qualification or training. In particular, the guidance describes the approach to be followed to ensure the information included in medical device patient labeling will be interpreted correctly and duly consider ensuring the use of the device safely and efficiently. At the same time, provisions of the guidance are non-binding, neither intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. Moreover, the authority also mentions that an alternative approach can be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance. 


Pretesting: Key Points 

The aspects addressed in the document include, inter alia, the ones related to pretesting. According to the guidance, pretesting of medical device patient labeling is the systematic and formal gathering of the target audience’s reaction to medical device patient labeling’s content and format, before the medical device patient labeling is issued in final form. As further explained by the FDA, pretesting constitutes the evaluations to be carried out when developing a medical device patient labeling and its content. The authority mentions that pretesting could be useful for:

  • Determining which of several labeling presentations is most effective for the intended audience and in identifying strengths and weaknesses in the presentation;
  • Identifying sensitive and controversial elements;
  • Revising and improving materials before distribution to users; and 
  • Identifying the best method to distribute the labeling to the target audience. 


Pretesting Methods 

The authority further describes the approach to be applied by a medical device manufacturer when determining a specific pretesting method to be used. According to the guidance, pretesting methods the manufacturer may use include various interviews, as well as questionnaires and testing (e.g., usability, readability). The purpose of pretesting could be to check whether the medical device patient labeling in question is understandable for potential users and whether they can follow the instructions provided therein to use the device safely and efficiently. At the same time, user-oriented testing could help identify the issues related to the accuracy, comprehensiveness, and overall organization of patient labeling. 

To assist medical device manufacturers in determining the most appropriate pretesting methods to be used, the authority describes the main ones in detail. 

  • Individual in-depth interviews – during such interviews, the persons who are representative in terms of potential users are asked to share their ideas and overall impression regarding the way the information contained in medical device patient labeling could be provided to improve its efficiency and clarity.
  • Focus group interviews – an interview with around 10 people involved, asked to share their opinions and beliefs concerning the labeling (such a discussion should be guided by a skilled moderator).
  • Self-administered questionnaires – in this case, persons who represent potential users of the device in question are asked to answer several questions in writing within a specified period. 
  • Usability testing – a special type of testing intended to assess the ease of use. Under the general rule, the usability of a product is composed of the combined usability of the product’s sub-components, which can include hardware, software, menus, icons, messages, labels, manuals, reference materials, and software-based help. Thus, when assessing usability, the party responsible for the device may focus on all the above mentioned aspects or some of them. Thus, usability testing stands for a technique designed to determine how usable a product is. In this case, the assessment includes observations made when the intended users of the device are trying to use it for the intended purpose; and also a collection of use-related information and feedback from such users. In the course of the said assessment, users are trying to use the device by the instructions provided in the medical device patient labeling, while all their actions are being rigorously analyzed. The information collected in the course of such testing allows the party responsible for the device to identify potential user errors, as well as the issues users may face when using the device. The main purpose of the usability testing is to demonstrate that medical device patient labeling provides sufficient information for the users to be able to use the product safely and efficiently. 


General Checklist 

As a final element, the guidance contains a checklist to be used by medical device manufacturers when assessing the completeness of medical device patient labeling they are going to use. According to the document, medical device patient labeling should contain the following elements: 

  • Table of Contents
  • Glossary
  • Descriptive Information:
    • Purpose of the device (indications for use)
    • Description of the device 
    • When the device should not be used (contraindications)
    • Risks and benefits
    • Expectations of the device and the procedure associated with the device
    • General warnings and precautions 
    • Importance of the need to adhere to a care regimen 
  • Operating Information:
    • Setup instructions
    • Checkout procedures
    • Operating instructions
    • The importance the need to monitor the activity of the device 
    • Cleaning instructions
    • Description of maintenance and who should do it
    • Storage instructions 
    • Expected failure time and mode and its effect on the patient
    • Instructions on how to safely dispose of the device 
    • Instructions on accessories 
    • Instructions on related, additional devices 
  • Troubleshooting information
  • Additional Information 
    • Clinical studies
    • Disease and self-care information 
    • Adverse events
    • Warrant
    • Travel or international use 
  • Index
  • Date of Printing 
  • User Assistance Information 

In summary, the present FDA guidance outlines the key points to be considered concerning medical device patient labeling information. The document highlights the main principles to be followed when developing patient labeling and also provides recommendations regarding the way the effectiveness of the labeling can be verified. 


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