FDA Issues Guidance on IDEs for Early Feasibility Medical Device Studies

September 30, 2013—The US Food and Drug Administration has issued its guidance on investigational device exemptions (IDEs) for early feasibility medical device clinical studies, including certain first-in-human studies.

The final guidance document can be downloaded from the FDA website. The draft guidance document was first made available for review and comment in November 2011. 

In its conclusion to the document, the FDA noted that early feasibility studies may be used to provide proof of principle and initial clinical safety data. The data from an early feasibility study may lead to device modifications and be used to refine the bench, analytical, and in vivo animal studies, as well as future clinical study protocols.

According to the FDA, conducting an early feasibility study under an IDE provides a unique opportunity 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.

A flexible process that relies on sound nonclinical assessments and appropriate risk-based rationales will benefit the initiation of an early feasibility study and the progression toward a pivotal study. A high degree of interaction between the FDA and the sponsor and use of the presubmission process will be instrumental in the successful implementation of this guidance, advised the agency.