The FDA has released final guidance on assessing the risks and benefits of investigational device exemption (IDE) applications for human clinical studies.
Assessments must include an analysis of all incremental risks to which patients will be exposed by the investigation, as well as how the risks will be minimized. Specific factors include:
The assessment of benefits should focus on concrete rather than hypothetical benefits and should include:
Risks and benefits to healthcare workers and others involved with the study also should be considered, as well as interpretive risks such as the likelihood of drawing false conclusions from the data.
The final guidance is similar to draft guidance issued in June 2015 but clarifies that the FDA will not disapprove an IDE based on study design. However, it does state that well-designed studies are more likely to produce important knowledge about a device or disease, and poorly designed studies can lead to false conclusions.
Read the final guidance here: www.fdanews.com/01-12-17-IDEguidance.pdf.