The new article describes the types of medical devices covered by the scope of the guidance and highlights the key points to be taken into account in this respect. 

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 design considerations for pivotal clinical investigations for medical devices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, 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 existing legislation and has been agreed with the authority in advance. 


Types of Medical Devices: Key Points 

According to the guidance, its scope covers two broad categories of medical devices based on the intended use: (1) therapeutic and atheistic devices and (2) diagnostic devices. The appropriate determination should be based on the claims made by its manufacturer by the virtue of the indications for use reflected in the labeling. The document further describes both types of medical devices in detail and highlights the key points associated thereto to assist medical device manufacturers and other parties involved with following the applicable regulations. 

Types of Devices Based on Intended Use 

First of all, the authority provides additional clarifications regarding the way medical devices should be distinguished based on their intended use. As it was mentioned before, the two main categories are:

  • Therapeutic devices – the ones that are generally intended for use in the treatment of a specific condition or disease. The first category also includes aesthetic devices – the products intended to provide the desired change in visual appearance through physical modification of the bodily structure. 
  • Diagnostic Devices – the second category covers such products as devices that provide results that are used alone or with other information to help assess a subject’s health condition of interest, or target condition, where the target condition states for a specific state of health (e.g., a particular disease). This category includes in vitro diagnostic (IVD) devices, diagnostic imaging systems, as well as the devices used for measurement or the algorithms used to analyze the data. The authority additionally emphasizes that the actual scope of functionality for diagnostic devices is quite broad – it is not limited to identifying the presence of a specific disease, but can also include providing any additional information about the state or condition of the human body. 

Concerning the intended use, the authority also mentions that some of the products could have more than one intended use, and this should be also considered when determining the type of device. For instance, a medical device could not only diagnose a specific condition but also provide the necessary treatment. Furthermore, some of the devices may fall into one of the categories outlined hereinabove while having more than one intended use within the same category. In such situations, an additional clinical investigation may be required to properly address all the aspects related to the safety and effectiveness of the device. 


Special Considerations for Clinical Studies of Devices 

The document also describes specific aspects to be taken into consideration when designing a clinical study – the ones applicable to any medical device (even though the study design will depend on the device type). The authority further outlines the main characteristics and features to be considered in this respect, namely:

  • The way the device operates (principal mode of action). According to the guidance, in all devices, an understanding of the scientific principles underlying device function and mechanism of action may be relevant in assessing performance and the adequacy of the proposed study design. The authority additionally emphasizes the importance of this information in the context of Pre-Submission. 
  • Training and skill level required for intended users. In certain cases, users may need additional training to be able to use the device safely and efficiently. Furthermore, a certain level of qualification is required for some of the devices, especially concerning implantable ones – due to the complexity of such devices and the high risks associated thereto. In some cases, multiple healthcare professionals having the necessary qualifications should be involved. 
  • Learning curve. The authority acknowledges that for some of the devices there is no sufficient data, hence, there is a learning curve associated with such products. In this respect, the authority emphasizes the importance of a rigorous assessment and collection of additional information before using the novel device for patients. Such products should not be used in certain situations – for instance, they are not suitable for home use. Should it be identified that additional information is to be collected, it is important to ensure such information is properly collected and analyzed. 
  • Human factors considerations. When making decisions related to the design of the device, medical device manufacturers should also take into consideration the human factors associated with the device. 

In summary, the present guidance highlights the key points to be taken into consideration concerning pivotal clinical investigations depending on the type of device in question. The authority describes the main types of devices and outlines the most important aspects associated with each of the types. 



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