The new article highlights the aspects related to the intended users of the devices – laypersons having no formal qualification or any background in healthcare, as well as the ones related to design considerations.
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 design considerations for devices intended for home use. The guidance is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved. In particular, the document outlines the key points arising from the specific nature of home-use products. It is important to mention that provisions of the guidance are non-binding in their legal nature. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to the intended users of the device, who differ significantly from healthcare professionals – usual users of medical devices. In this respect, the authority states that home users can have a large range of physical, sensory, and cognitive capabilities and disabilities, and emotional differences that should be considered in [the] home use device design. Furthermore, the FDA additionally emphasizes that in case the device is not easy to use, and the way it should be used is not clear and understandable, the likelihood of misuse and issues associated thereto will increase significantly. Hence, the manufacturer should take all the steps to prevent misuse cases that could be reasonably foreseen at the design and development stage. It should be taken into consideration that the device could be used inappropriately, resulting in additional risks arising.
The document outlines the characteristics that could impact the use of the device and, consequently, should be taken into consideration by the device manufacturer. The authority explains that the characteristics of intended users should be considered carefully by the medical device manufacturer at the early design and development stage. For instance, the product could be intended to be used by individuals with impairments, and this should be duly considered when analyzing the use scenarios. It is important to mention that in case a premarket submission is required due to the regulatory status of the product, a submission dossier should include, inter alia, a summary of actions taken by the medical device manufacturer concerning the aforementioned characteristics, which are further described in detail in the present guidance.
According to the guidance, when developing the product, the manufacturer should consider its acceptability for users with a range of physical sizes, mobility, dexterity, coordination, flexibility, strength, and stamina.
Another important aspect to be taken into consideration by a medical device manufacturer is related to the vision and hearing abilities of the intended users, as well as their tactile sensitivities. For instance, the authority mentions that the manufacturer shall make sure the interface of the device remains visible in various use conditions that are common for the home use environment. Furthermore, the sound signals the device may produce should differ from the sounds that are common for the intended use environment to an extent sufficient to ensure their proper identification by the users. The feedback mechanisms employed should provide clear and understandable feedback on all interactions with the user, especially in case the device is intended to be used by persons with impairments.
It is also stated that during the initial development of a home-use medical device, the manufacturer should consider the cognitive abilities of its intended users and whether they could have any cognitive impairments impacting their abilities to process information. In this respect, the authority also emphasizes the importance of considering the experiences the potential users are expected to have with the devices of the same type or similar products, as well as the users’ ability and will to learn the proper way to use the device.
In certain cases, the devices will be used to provide care to someone who cannot use them without external assistance. Apart from this, the manufacturer should make sure the device could be used safely and efficiently by users that are in different mental conditions.
Apart from the aforementioned aspects related to the potential users, the scope of the guidance also covers the matters related to design considerations. In this respect, the authority refers to the Quality System (QS) regulation that outlines the requirements the device should meet to ensure its safety and effectiveness. The document outlines the most important aspects to be considered concerning technical issues, including the ones related to the design control for home-use devices.
According to the applicable regulation – 21 CFR 820.30 – a manufacturer must establish procedures to ensure that device design will translate into a device that performs properly according to its intended use and user needs. As further explained by the FDA, the QS requirements should be followed concerning the design and development, packaging, labeling, as well as cleaning and sterilization procedures of the device should be subject to. Thus, according to the guidance, a medical device manufacturer should duly consider specific aspects associated with the home use environment to ensure the device will be used safely and efficiently for its intended purpose.
It is also important to mention that a risk management plan could be developed, outlining the approach to be applied to identify potential hazards associated with the use of the device and malfunctions that could take place. In this respect, the authority states that home-use devices are subject to a wider range of hazards than the one intended to be used by healthcare professionals in the clinical environment. The said plan should also address the aspects related to risk control and human factors engineering methods.
In summary, the present guidance describes in detail the approach to be applied concerning user considerations. The document highlights the key points to be taken into account by medical device manufacturers to ensure the product meets the customers’ needs and could be used by laypersons.
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