FDA Clarifies IDE Risk-Benefit Assessment

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 type of risk, such as physical safety, serious injury or illness, procedure-related complications, risks of the study itself, and false positives or false negatives for diagnostic devices;
• The likelihood of the risk;
• The duration of the risk; and
• Possible risk-mitigation approaches.

The assessment of benefits should focus on concrete rather than hypothetical benefits and should include:

• The type of benefit, such as the device’s anticipated impact on health or clinical management;
• The magnitude of the benefit;
• The likelihood of participants experiencing a benefit; and
• The duration of the effects.

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The final guidance is similar to draft guidance issued in June 2015 but clarifies that the FDA will not disapprove an IDE based on study design.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.