The new article provides an overview of the regulatory requirements related to the information on human factors to be submitted when applying for marketing approval.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the content of human factors information in medical device marketing submissions. Once finalized, the document will provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, it is important to mention that guidance documents issued by the FDA are non-binding in their nature, nor are 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 current legislation and has been agreed with the authority in advance. The present draft guidance has been released for public consultation – the authority expects feedback and suggestions from the industry to be considered when finalizing the document. 


Regulatory Background

First of all, the authority states that one of its main goals is to create a favorable environment for the development and supply of medical devices while ensuring their continued safety and proper performance. This includes, inter alia, the assessment of risks and benefits associated with the products allowed to be marketed and used in the US. The authority additionally emphasizes the importance of device-user interface interactions for ensuring the safe use of medical devices. In this respect, medical device manufacturers should conduct an assessment of human factors related to the human-device interface when the product is being developed. By the virtue of this guidance, the authority intends to outline the key human factors to be taken into consideration when preparing a submission for marketing approval. 

As further explained by the FDA, the goal of the human factors assessment is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible; the main factors to consider in a risk-based approach to human factors assessment, as described in this draft guidance, include the identification of (i.e., presence of or modification to) critical tasks and the elimination or reduction of use-related hazards. The recommendations included in the document address the matters related to the content of human factors and usability engineering information the authority expects medical device manufacturers to provide. These recommendations are applicable with respect to different regulatory pathways used when placing new products on the market including, inter alia, premarket notification (510(k)) submissions, premarket approval applications (PMAs), or De Novo classification requests. However, the authority acknowledges that in certain situations, the risks associated with human factors cannot be eliminated in full. 

According to the guidance, when preparing a marketing submission, medical device manufacturers should demonstrate that the product is safe and efficient when used for its intended purpose and that the needs of the intended users are duly taken into account during the design stage. This means that the information to be included in the submission should cover, inter alia, the aspects related to the critical risks (if any), validation testing undertaking, as well as residual risks – the ones that are still present after all the measures are duly taken.

Legal Framework and Implementation

Once finalized, the present guidance document is intended to supersede the draft guidance “List of Highest Priority Devices for Human Factors Review”, and also to be used together with the guidance document “Applying Human Factors and Usability Engineering to Medical Devices”. The latter provides recommendations with respect to the way human factors should be taken into account when developing new medical devices and pays special attention to the user interface. At the same time, the present document is more dedicated to the application of a risk-based approach in the context of human factors. Furthermore, it is also stated that the aforementioned guidance on human factors will be revised as well. In particular, a new revision will include new definitions, as well as certain changes to the information related to documentation. 

The document also contains references to the FDA-recognised voluntary consensus standards – the ones medical device manufacturers may use in order to demonstrate that the products they are responsible for complying with the applicable regulatory requirements. 

As it is mentioned in the draft guidance, the authority expects it will take up to 60 days for the industry representatives, as well as the authority itself, to implement the policies described therein. 

The authority additionally emphasizes that the present document does neither describe the way human factors evaluation should be performed nor describes the general rules for submitting applications with respect to new medical devices or the ones already placed on the market. 



In order to assist medical device manufacturers and other parties involved in interpreting the regulatory requirements described in the guidance, the document provides definitions of the most important terms and concepts used in the context of human factors including, inter alia, the following ones: 

  • Abnormal use – an intentional act or intentional omission of an act that reflects violative or reckless use or sabotage beyond reasonable means of risk mitigation or control through design of the user interface. 
  • Critical task – a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. 
  • Human factors engineering – application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software) systems and tasks to achieve adequate usability. 
  • Human factors validation testing stands for testing conducted at the end of the device development process to assess user interactions with a device user interface to identify use errors that would or could result in serious harm to the patient or user. 

In summary, the present FDA guidance provides an overview of the regulatory framework related to human factors and their consideration when developing new medical devices. The document explains the approach the authority applies and provides definitions of the main terms used. 



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