The present article provides a brief overview of the existing regulatory framework in the sphere of investigational device exemptions and describes special pathways to be applied to ensure the availability of novel medical devices.
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 early feasibility medical device clinical studies. The scope of the document also covers certain First in Human (FIH) studies. The guidance is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by study sponsors to ensure compliance thereto. However, the authority explicitly mentions that the provisions of the guidance are non-binding. Moreover, an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been agreed with the authority in advance.
Early Feasibility Studies: Key Points
As it was mentioned before, the scope of the present document covers the aspects related to the Investigational Device Exemption applications for early feasibility studies in the context of medical devices associated with high risk. The studies of this type are intended to collect initial safety-related information regarding the way the device operates when used in a clinical environment for its intended purpose. As explained by the FDA, the studies of this type are usually conducted in the early design and development stages when additional information is required, while there is no way to obtain such information by the virtue of non-clinical means. The authority additionally emphasizes the importance of a rigorous benefit-risk analysis to be conducted before commencing a study. Furthermore, a study sponsor (a party responsible for a study) should ensure that efficient measures are implemented to protect humans participating in a study.
According to the Federal Food, Drug, and Cosmetic (FD&C) Act; the Us regulating authority is entitled to grant devices for investigational use an exemption from certain requirements so that experts qualified by scientific training and experience can investigate their safety and effectiveness. This concept is referred to as an Investigational Device Exemption (IDE). The authority also mentions that in the case of medical devices with the high risks associated thereto, an interested party may apply for the authority’s approval first, before commencing the study. As further explained by the FDA, the scope of information to be submitted for review when applying for exemption should be determined based on the investigation in question and its specific features. The factors to be taken into consideration include, inter alia, the following ones:
- The scope and duration of clinical testing to be conducted under such exemption;
- The number of human subjects that are to be involved in such testing;
- The need to permit changes to be made in the device subject to the exemption during testing conducted by a clinical testing plan; and
- Whether the clinical testing of such a device is to develop data to obtain approval for the commercial distribution of the device.
The document further describes specific regulatory requirements to be followed when applying for approval and conducting the trial under the framework described herein. In particular, the authority emphasizes the following aspects:
- An application to be submitted by an interested party should contain all the information the FDA will need to assess the request, including the investigational plan and report of prior investigations.
- An investigational plan should address such matters as the purpose of investigation, the protocol, risk analysis, description of the device, monitoring procedures, labeling, consent materials, and information about the Institutional Review Boards (IRB) reviewing the investigation.
- Report of Prior Investigations should provide information about any testing the device was subject to before applying for an IDE.
- Supplemental applications should be submitted in case of changes to the Investigation Plan in case such changes are subject to prior approval, or to notify the authority in situations when prior approval is not required.
The guidance provides additional clarifications regarding the regulatory requirements outlined hereinabove and explains the way they should be interpreted and followed.
Terms and Definitions
To assist study sponsors and other parties involved in operations with medical devices, the document also provides definitions of the most important terms and concepts used in the context of early feasibility studies and investigational device exemptions associated thereto. The terms explained by the FDA include, inter alia, the following ones:
- Early feasibility study – a limited clinical investigation of a device early in development, typically before the device design has been finalized, for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel application). The authority further explains that such studies usually involve a limited number of participants, and are intended to collect initial information regarding the safety and effectiveness of a new device when used in a clinical environment. The information and data collected through early feasibility studies cannot be collected in any other way. This information will further be used to decide on changes necessary to ensure the safety and effectiveness of the product in question.
- First in human (FIH) study – a type of study in which a device for a specific indication is evaluated for the first time in human subjects. The authority mentions that the scope of the present guidance covers only FIH studies that are considered to be early feasibility studies.
- Traditional feasibility study – a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. The study of this type usually takes place in later development stages, so the manufacturer should already have sufficient information about the device and its performance. The authority mentions that the traditional feasibility study could be conducted even without conducting an early feasibility study in advance.
- Pivotal study – a clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically unjustified number of subjects.
As further explained by the FDA, early feasibility studies could be carried out to collect additional information regarding the safety of the device, its usability, issues arising when it is used for its intended purpose, actual effectiveness and performance, specific characteristics of patients that could potentially impact the way the device operates, and other aspects associated with the use of the device.
The present FDA guidance provides an overview of the applicable regulatory requirements in the sphere of early feasibility studies in the context of applications for an investigational device exemption. The document also clarifies important aspects regarding the existing regulatory framework and highlights the aspects to be taken into consideration by study sponsors and other parties involved.
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