The FDA has released its final guidance on Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies. It aims to encourage medical device innovation in the US and improve patient care and safety as well as a patient’s access to clinical trials and treatments. This program will create a more collaborative approach between inventors, developers, investigators, and regulators and will provide the earliest patient access to medical devices. Early Feasibility Study (EFS) will have a small number of subjects and will be for a device that is intended for a specific indication that may be early in development and does not necessarily involve the first clinical use of a device.
According to the FDA, “This guidance outlines new policy regarding the application for and approval of early feasibility study IDEs. Two important elements of the guidance are:
- FDA approval of an early feasibility study, including some first-in-human studies, may be based on less nonclinical data than would be expected for other types of studies (e.g., traditional feasibility or pivotal).
- The introduction of new approaches to facilitate timely device and clinical protocol modifications during an early feasibility study, while still maintaining compliance with FDA human subject protection requirements, including obtaining informed consent and Institutional Review Board (IRB) (or ethics committee) oversight.” (FDA)
Approval of an early feasibility study IDE may be based on less nonclinical data. Conducting an early feasibility study under an IDE also requires a report of prior investigations and an investigational plan. “To improve the likelihood of IDE approval, the following questions should be addressed with supporting information in the original early feasibility study IDE application:
1. What is the clinical condition to be treated or assessed by the device?
2. What is the standard of care for the clinical condition and expected clinical outcomes associated with the standard of care?
3. What are the anticipated benefits associated with use of the study device?
4. Is the information included in the Report of Prior Investigations adequate to support initiation of the study?
5. Does the Investigational Plan include a thorough risk analysis, sufficient risk mitigation strategies, adequate human subject protection measures, and an appropriate clinical study protocol?
6. Are the potential risks associated with the device use likely to be outweighed by the anticipated benefits of the early feasibility study, that is, is initiation of the clinical study justified based on the clinical need for the device, Report of Prior Investigations and Investigational Plan?” (FDA Guidance Section 5)
Overall, this program will create the ability to “obtain clinical experience with a new or modified device or new clinical use, while utilizing appropriate subject protection measures and good clinical study practices. Vital clinical information can be captured and used to optimize the device design, design evaluation, and clinical investigation plans.” (FDA)