The article provides a brief overview of the regulatory requirements for medical devices for nocturnal home hemodialysis and highlights the key points to be considered by medical device manufacturers for such products.
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 the Investigational Device Exemptions (IDEs) for devices intended for nocturnal home hemodialysis. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers 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. 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. The present guidance represents the current FDA position on the matter, and could be subject to changes, should such changes be reasonably necessary to reflect the corresponding changes to the underlying regulations.
As it was mentioned before, the present guidance is intended to assist medical device manufacturers in submitting Investigational Device Exemption (IDE) applications related to nocturnal home hemodialysis (NHHD) systems used to administer dialysis therapy while the patient is sleeping. Such products are intended to be used outside the clinical environment.
The authority explicitly states that the guidance describes the approach that is expected to be the least burdensome for the medical device manufacturers involved in operations with medical devices covered by the scope of the guidance while ensuring the safety and proper performance of such devices. At the same time, the parties involved are encouraged to share their feedback and suggestions regarding the optimal approach to be applied when dealing with regulatory matters.
It is also stated that the scope of the present guidance covers only the products intended for clinical investigation while the matters related to the ones intended for conventional use are addressed in a separate guidance document issued by the FDA.
To ensure clarity, the authority provides definitions of both terms:
- Conventional Hemodialysis – is a type of chronic hemodialysis that takes place in a clinical environment and typically includes treatments performed three times per week for approximately four hours per treatment; the therapy is administered by a trained medical professional.
- Nocturnal Home Hemodialysis (NHHD) – a type of chronic hemodialysis that takes place in the home while the patient is sleeping, typically at night, up to seven times per week, for approximately six to ten hours per treatment, depending on the individualized dialysis prescription; it is administered by the patient or a trained partner, rather than by a trained medical professional.
The document also indicates the applicable product codes and outlines the devices falling outside its scopes, such as hemodialyzers, hemofilter, or hemoconcentration.
As further explained by the authority, NHHD systems covered by the scope of the document are presumed to be medical devices associated with significant risk, hence, any clinical investigation must be conducted in conformance with the Investigational Device Exemptions (IDE) regulations, 21 CFR Part 812. Apart from the aforementioned regulation, the parties involved in activities with such devices should ensure compliance with the regulatory requirements related to the institutional review boards and informed consent. Furthermore, the authority encourages medical device manufacturers to get in touch before applying to discuss the requirements for clinical data. For the IDE-specific requirements and recommendations, the authority refers to Investigational Device Exemptions Policies and Procedures in CDRH Device Advice.
The document also outlines the scope of information the authority expects to be included in a submission. For instance, it is recommended to provide information covering the main safety-related matters and components of the system, including a description of the physical and electronic components, system features and functions, and software.
Physical and/or Electronic Description
According to the guidance, the medical device manufacturer shall provide a detailed description of the NHHD system in question. In particular, the authority suggests using diagrams to illustrate the way the elements of the system are connected among each other, as well as the interfaces used. It is stated that the manufacturer shall provide a detailed description of all the components of the system and their specifications. As explained by the FDA, the key components of an NHHD system usually include:
- Ultrafiltration controller mechanism;
- Air detector system;
- Blood leak detectors;
- Patient disconnection or exsanguination preventers and detectors;
- Heat exchangers;
- Access ports for external remote monitoring devices;
- Anticoagulant pumps or supply; and
- Other safety features.
Apart from the elements and components listed herein above, some of the systems can also include the following ones:
- Water treatment system;
- Integrated remote patient monitors; and
- Dedicated tubing sets.
As it was mentioned before, the authority encourages medical device manufacturers to use diagrams to describe the relationship among the components of the system, as well as processes and procedures associated with the use of the device.
Furthermore, the manufacturer shall duly identify the elements of the system (and respective materials) that are in contact with the patient or fluids and also the sensors applied to the patient.
The manufacturer shall also describe the system’s patient/user interface and explain the way the patient is expected to interact with the system, including the details on the specific measures taken to ensure that the device will be used safely and efficiently.
In summary, the present guidance provides an overview of the regulatory requirements to be applied for NHHD systems. The document provides definitions of the most important terms and concepts and also outlines the key aspects to be considered by medical device manufacturers before applying to the FDA.
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