The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to 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 present document constitutes a final version of the guidance issued by the FDA earlier in November 2011.
Due to its legal nature, the document does not introduce any regulatory requirements itself but provides additional clarifications and recommendations to be considered by the parties involved. The Agency also states that an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance.
The present FDA guidance describes the day the Investigational Device Exemption framework should be applied in the context of early feasibility studies related to the medical devices associated with high risk. Such studies could be carried out in order to collect initial clinical data to be later used to assess safety-related aspects associated with the medical device. It is reasonable to conduct them in the early development stage in case the nonclinical methods available do not provide the opportunity to collect all the data necessary for further development. The Agency additionally emphasizes that each time an early feasibility study is initiated, the responsible party shall conduct the appropriate benefit-risk analysis and implement all the measures necessary to ensure the safety of human subjects participating in the study to the maximum extent possible.
According to Section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA, as the US regulating authority in the sphere of medical devices, is entitled to exempt some medical devices from certain regulatory requirements, provided the products subject to such an exemption are intended for investigational use. Under this framework, qualified experts are allowed to carry out the clinical studies necessary to collect additional data required to assess and evaluate the main factors related to the safety and performance of such devices. Should the medical device be associated with significant risk, an interested party shall file the appropriate application in order to obtain approval from the regulating authority before commencing the early feasibility clinical study.
It is also important to mention that the scope of information about the medical device an interested party shall provide when applying for the IDE will be based on the investigation. According to the document, the factors to be considered in this regard include:
- 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 in accordance with a clinical testing plan required under paragraph (3)(A); and
- –Whether the clinical testing of such device is for the purpose of developing data to obtain approval for the commercial distribution of the device.
The authority states that early feasibility studies should comply with any and all applicable regulations establishing the requirements for clinical studies. In particular, a responsible entity shall provide the following:
- An application containing general information about the study;
- An investigational plan, which should describe the purpose of the investigation, the device itself, as well as risk analysis and monitoring procedures;
- A report of prior investigations containing information about all prior testing the product in question has been subject to;
- A supplemental application to be submitted in case of changes to an investigation plan or medical device itself, provided such changes require prior approval of the regulating authority or the appropriate notification if the approval is not required.
The document also provides the definitions of the most important concepts used in the context of investigational device studies, namely:
- A first in human (FIH) study stands for a type of study in which a device for a specific indication is evaluated for the first time in human subjects.
- A traditional feasibility study is 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.
- A pivotal study is 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 justified number of subjects.
Early Feasibility Studies in Detail
According to the document, early feasibility studies could be conducted in order to obtain preliminary information regarding the safety-related matters arising when the medical device in question is used for its intended purpose. Additionally, they facilitate the identification of patient characteristics that could also impact the performance.
The authority states that while clinical studies, in general, are intended to collect the data necessary to assess the safety of a medical device, early feasibility studies have a wider scope of application. They could be conducted during early product development stages, and information collected could be used to improve the product itself or certain processes associated thereto.
The document further describes the particular cases in which the specific type of clinical studies should take place. According to the guidance, such a determination should be based on the novelty of the medical device in question, its intended purpose, and also the amount of test data available to support the IDE application. As mentioned, an early feasibility study could be conducted if the information necessary could not be collected in the course of a nonclinical assessment. However, the authority reserves the right to make a final determination on whether an early feasibility study could be performed.
FDA Policy for Early Feasibility Study IDEs
The present FDA guidance describes in detail the regulatory policy applied by the authority regarding early feasibility studies related to investigational devices. The core points of the regulatory approach are the following:
- The Agency may grant approval for the commencement of an early feasibility study having less nonclinical data than required for other types of clinical studies. The FDA acknowledges that the information available on the early product development stages could be insufficient, so the threshold of supporting information to be provided is lower than in other cases.
- The new policy adopted by the FDA also covers the aspects related to modifications. In particular, more types of modifications can be made under a 5-day notification without prior FDA approval, as compared with other types of studies.
In summary, the FDA guidance on early feasibility studies for investigational devices describes the regulatory approach employed by the authority and also highlights the most important aspects which are specific for this type of clinical trial. The document also outlines the differences in regulatory approach in comparison to the traditional feasibility studies.
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