The article provides additional details regarding the aspects related to training and labeling to be reflected in an investigational plan.
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 Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis (NHHDs). The document provides an overview of the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. At the same time, it is important to mention that FDA guidance documents are non-binding, and are not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing framework. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the corresponding legislation and has been agreed with the FDA in advance.
The scope of the guidance covers, inter alia, the aspects related to an investigational plan to be developed by a party responsible for the trial. This includes the matters related to the training the persons involved should undergo, as well as the labeling requirements to be followed.
Training: Key Points
According to the guidance, the subjects participating in a clinical trial should be trained properly on how to use the device and perform the procedures associated thereto. Furthermore, it is stated that the training team should check the ability of the study participants to perform all the procedures correctly before the said subject will use the device subject to investigation in the home environment. As further explained by the FDA, the training team’s observations should include observing the subject’s or care partner’s ability to troubleshoot the device and other procedure-related issues. The time it will take to complete the training depends on numerous factors, hence, it is advised to check the effectiveness of the training by conducting a practical test or asking the study subject to answer a few questions in writing. The authority also recommends outlining the responsibilities of the care partner during the training sessions and providing instructions to subjects and care partners on emergency procedures, such as the procedures necessary if a serious adverse event occurs. The document also provides certain device-specific recommendations based on the intended use of NHHDs and aspects associated thereto.
According to the guidance, the scope of training to be organized should also cover the aspects related to the regular maintenance the device requires, as well as sampling and management of supplies needed to ensure the proper operations of the device.
The IDE application submitted should address the aspects related to training – in particular, it should include copies of the training manual, questionnaires, checklists, and any materials that are intended to be used in the course of the study to ensure the proper training of study participants.
Another important aspect addressed in the guidance relates to labeling. It is stated that the IDE application must comply with the labeling requirements described in 21 CFR 812.5 and must include draft device labeling for the NHHD system (e.g., the operator’s manual, patient labeling, any labels that will be affixed directly to the system or its accessories). The authority encourages medical device manufacturers to provide the labeling containing information the users would reasonably need to use the device safely and efficiently, as well as recommendations regarding the actions to be taken in case of any issues arising during the use of the device. The document further outlines the main elements to be included in labeling and highlights the key points associated thereto.
- Therapy Background. First of all, the manufacturer shall describe the functions the device is intended to perform, its target population, and the principle of operation. This section could also include additional details regarding the way the device should be used, as well as any contraindications or precautions.
- Device Description. This section should provide a detailed description of the device itself, and all of the components thereto. In particular, it should contain the details about:
- The safety-related components included in the system (e.g., ultrafiltration controller, arterial and venous pressure sensors, disconnection preventers and sensors); and
- The accessories that need to be used with the system (e.g., extracorporeal tubing, replacement fluids).
- Device Operation. This section should provide the details regarding the steps to be taken by a person using the device to ensure it operates properly when used for the intended purpose. In case it is possible to use the device in more than one configuration, all the configurations should be described as well, together with the appropriate instructions provided.
- Alarms and Troubleshooting. This section should provide information about the alarms, potential reasons behind them, and steps to be taken by a person using the device.
- Cleaning, Disinfection, and Preventive Maintenance. It is also important to provide information about the actions to be performed to ensure proper operations of the device within the whole expected useful life. For instance, it will be necessary to explain the way the device should be cleaned and disinfected (concerning the latter, the authority refers to the section of the guidance describing reports of prior investigations).
Apart from the above mentioned aspects, the authority also states that the operator’s manual, which is a part of medical device labeling, should provide the following:
- Instructions for the subject or their care partner to properly use, monitor, and verify the conductivity and temperature of the dialysate used in the NHHD system; and
- Instructions for the subject or their care partner to properly monitor and adjust the dialysis treatment to ensure proper fluid balance.
It is also important to mention that since NHHD systems are devices intended to be used in a home environment without healthcare professionals involved, the manufacturer should pay special attention to patient labeling. As further explained by the FDA, the manufacturer should make sure all the information is provided in a way making it possible for intended users to understand it.
In summary, the present guidance addresses certain specific aspects related to investigation plans for NHHD systems. The document outlines the key points to be considered concerning the training the study subjects should undergo before the commencement of the trial, as well as labeling and information to be communicated to intended users.
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