FDA To Allow "Additional Flexibility" In IDE Benefit-Risk Assessments
The U.S. Food and Drug Administration has released a new guidance to clarify factors the agency considers when evaluating benefit-risk assessments in an investigational device exemption (IDE). Seeking to reduce unnecessary delays in device development, the FDA indicates that it will extend “additional flexibility” to devices seeking an IDE in early stages of development.
An IDE provides the rationale for why a device is considered to be both safe and effective for human use, and it must be granted before a device sponsor may proceed to human clinical trials. To receive an IDE, a sponsor must prove that the expected benefits outweigh any possible risks.
The new guidance, published in the Federal Register, seeks to provide “greater clarity for FDA staff and IDE sponsors and sponsor-investigators regarding the principle factors that FDA considers when assessing the benefits and risks of IDE applications for human study.”
The key to expeditious IDE approval, says the FDA, is a balance of certainty and risk mitigation. The guidance further stipulates that the FDA is prepared to accept a certain degree of uncertainty if appropriate risk-mitigating measures are in place.
There is likely to be substantial uncertainty surrounding a product that never has been tested in humans, particularly novel technologies in an early stage of development, the FDA explained.
The agency wrote, “For proposed IDE studies, at earlier stages of device development, FDA considers appropriate mitigation measures for anticipated possible risks and unanticipated risks, whereas in later stages, risk mitigation focuses increasingly on the most probable risks.”
The document also focused on the need to carefully control informed consent for potential participants in clinical trials, with one section calling for patient preference information (PPI) to be included in IDE applications.
In May, the FDA released a separate guidance explaining how patient preference could be included in device approvals, saying “the Agency understands that patients and caregivers who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights and perspectives on the benefits and risks of devices.”
The purview of that guidance extended to devices under PMA, HDE or de novo review, but now the agency has now clarified how PPI might be used in IDE applications.
The overall purpose of the new guidance was to provide a “framework” by which sponsors and sponsor-investigators might compile data from a variety of different sources — including clinical, non-clinical, and PPI to provide the FDA a more complete picture of the device’s benefit-risk profile.
According to the guidance, the FDA “intends to permit appropriate latitude for the conduct of IDE studies within the boundaries of applicable laws and regulations.”
The FDA will accept comments on the draft for the next 90 days.