FDA states that a primary purpose of the draft guidance is “to clarify the factors that FDA considers when assessing risks and anticipated benefits for approving IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures which can assure appropriate patient and research participant protections in investigational research settings.”
The draft guidance states three considerations made by FDA in assessing the benefit-risk of an IDE:
1.Stage of development of the device
2.Maturity of the proposed technology
3.Availability of non-clinical testing to complement or replace the need for clinical testing
FDA acknowledged that “device investigations during different stages of development are generally associated with different types of risk, and different levels of uncertainty.” For example, “a greater degree of uncertainty is expected for novel technologies, and at earlier stages of device development, such as first in human or early feasibility trials, while relatively more certainty is expected in traditional feasibility and pivotal trials.” The benefit-risk assessment “should focus on whether a proposed study is well-designed to meet its stated objectives as appropriate to the stage of development for the investigated device.”
The draft guidance elaborates somewhat on many of these factors and concludes with two appendices, the first setting forth a proposed outline for sponsors to follow when summarizing the primary benefits and risks of a proposed IDE and the second setting forth hypothetical examples.