The new article highlights the key points related to the reports of prior investigation.

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 indicated for Nocturnal Home Hemodialysis (NHHD). The document provides an overview of the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, neither is intended to introduce new rules or impose new obligations. Moreover, an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance. 

The scope of the guidance covers, inter alia, the aspects related to reports of prior investigations. As it is stated by the FDA, IDEs for NHHD systems must include the results from pre-clinical testing performed before a clinical study. The document further outlines the scope of information to be provided by the medical device manufacturers responsible for the NHHD system in question. 


Bench Testing 

First of all, the authority encourages medical device manufacturers to perform functional testing to ensure the system in general and all components thereof are operating as initially intended. According to the document, this functional testing should include validation of all of the system features under both standard operating conditions and worst-case conditions (e.g., treatment features, user interface, disinfection procedures, disconnect preventers and alarms, system sensors, controllers, monitors, alarms, and if applicable, water treatment and integrated remote monitoring capabilities). The manufacturers are also encouraged to perform a system-level hazard analysis with its scope covering, inter alia, the use of error-related hazards. The said analysis should be conducted to ensure the device will operate as intended and under the appropriate specifications. Alternatively, the manufacturer may provide a declaration of conformity with the standard ISO 147972 – the one addressing the matters related to risk management. The references to the applicable standard could be also made concerning electrical safety – in such a case, the applicable standard will be IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety. Apart from this, the manufacturer shall duly perform testing addressing the aspects related to electromagnetic compatibility, or make references to the applicable standard as well. In this respect, the authority additionally emphasizes that since NHHD systems are intended to be used in the home environment, which is quite different from clinical settings in terms of hazards and interferences, the aspects related to the specifics of the use environment would require additional attention to be paid. 

The product in question should have a system allowing it to transmit real-time alarms to a remote monitoring station, while the actual performance of the respective functionality should be checked in the course of the appropriate testing. 

If the product contains disposable components, such components should be subject to testing as well. In this respect, the authority refers to separate guidance dedicated to the matter. 

Biocompatibility Testing 

The FDA further encourages medical device manufacturers to perform biocompatibility testing following the respective guidance document named Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing. The scope of the said testing should cover the assessment of biocompatibility-related matters for all the elements and components of the system which are intended to be in direct and indirect patient-fluid contact. When determining the specific tests to be performed, the manufacturer should take into consideration the particular way the device will be used (i.e., the level and duration of contact with a patient). 

Apart from this, medical device manufacturers are encouraged to perform leach testing to identify the potential leachables, and also perform their risk assessment supported by technical literature. 


Sterility, Disinfection, and Expiration Date Testing 

Other aspects to be addressed in the course of testing to be performed by a medical device manufacturer for an NHHD system include, inter alia, the ones related to sterility, disinfection, and expiration date. In this respect, the authority highlights the following key points: 

  1. Sterility. The manufacturers are expected to provide detailed enough information regarding the sterilization methods used to demonstrate that the acceptable level of sterility is achieved, while the sterilization process used should be duly validated under the applicable regulatory requirements set forth by 21 CFR Part 820. 
  2. Disinfection. The manufacturers are also expected to provide details regarding the disinfection and reprocessing cycles, as well as the specific methods employed. According to the guidance, this description should include the steps the operator should follow to complete machine disinfection and methods for determining disinfectant residuals. The authority also mentions that in case the particular method used by the manufacturer is not used for another medical device already placed on the market, the details of validation should be provided accordingly. Should the manufacturer have any questions or concerns regarding the information to be provided, such questions should be discussed with the authority before submission. 
  3. Expiration Date Testing. The manufacturer shall provide the details about all the components of the system having expiration dates, and also provide the appropriate justifications explaining the way the exact dates have been determined. In this respect, the authority refers to the Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers for device-specific recommendations related to the expiration date testing for this type of product. 


Human Factors Recommendations 

The document also covers the aspects related to the assessment of human factors. In particular, the guidance describes the approach to be applied for usability testing. As explained by the FDA, usability testing should demonstrate that the device performs safely, under realistic conditions in the hands of prospective users, with minimal dependence on training and labeling as described in AAMI/ANSI HE74:2001, Human Factors Design Process for Medical Devices or equivalent methods.

In summary, the present guidance provides additional clarifications regarding the additional testing medical device manufacturers should conduct to ensure the safety and proper performance of NHHD systems. The FDA explains the aspects to be covered by each type of testing and highlights the key points manufacturers should pay attention to. 



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