EMERGO SUMMARY OF KEY POINTS:

• Final FDA guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered.
• The guidance finalizes draft recommendations issued by the FDA in 2015.
• The guidance includes recommendations for benefit and risk information IDE applicants should submit to the FDA for review and approval.

Final guidance from the US Food and Drug Administration lays out key factors the agency uses to assess benefits and risks of Investigational Device Exemption (IDE) applications for medical device clinical trials.

According to the FDA, the final guidance is intended to promote a more streamlined and predictable clinical trial evaluation and approval process, principally by providing a clearer idea of how the regulator evaluates benefit and risk information in IDE applications under review. A draft version of the guidance was issued in summer 2015.

“FDA believes use of this benefit-risk framework will facilitate the incorporation of evidence and knowledge from different domains—clinical, nonclinical and patient—to support a comprehensive, balanced decision-making approach” regarding IDE application approvals, states the guidance.

The guidance covers IDE applications, IDE amendments as well as IDE supplements.

Recommending a benefit-risk assessment framework

Included in the guidance are key factors the agency uses to assess IDE benefits and risks, as well as recommended information sponsors should submit as part of their IDE applications.

The framework sponsors should include in their applications should address the following issues:

• Context of proposed investigation: Summarizes disease or condition the proposed study targets, and describes both the device and the investigation’s objective and design.
• Assessment of proposed investigation’s risks: Summarizes key risks, and should cover risk charcterization, control measures and residual risks.
• Assessment of benefits: Identifies key benefits of the proposed investigation for study subjects and other parties.
• Considerations for patient preference data: Lists any available patient preference information.
• Assessment of uncertainty: Summarizes key sources of uncertainty regarding available evidence as well as in the proposed  investigation; justifies why identified levels of uncertainty are acceptable.
• Conclusion: Argues why factors listed above justify approval of proposed clinical investigation.

FDA reviewers, in turn, will use information provided by an applicant in the framework outlined above to determine whether a proposed clinical investigation’s benefit and risk profiles are acceptable. Considered in combination with the FDA’s Pre-Sub program to help manufacturers determine if clinical trials for their devices are necessary, the new guidance should help clarify clinical trial requirements, if any, facing US device market applicants.

More information on clinical trial and data requirements for US medical device market authorization can be found by reading our whitepaper on FDA 510(k) clinical data requirements; for details on US medical device registration requirements in general, download our in-depth video overview.