The U.S. FDA has outlined a risk-benefit framework aimed at reducing the chances of an IDE application being rejected.

In draft guidance issued June 18, the agency says it hopes to clarify some factors it takes into account when assessing the benefits and risks of starting clinical trials of investigational medical devices. For example, the stage of development of the device, the maturity of the proposed technology and the availability of nonclinical testing to supplement or replace the need for human testing are all considered by staff.

Given the anticipated and unanticipated risks associated with these devices, the FDA says it will allow “appropriate latitude” for the conduct of studies supporting IDE applications.

The guidance provides a framework sponsors can adopt for an IDE risk-benefit assessment, which should include the following elements:

• A summary of the disease or condition to be treated and a description of the device in the context of currently available treatments;
• An assessment of risks of the proposed investigation;
• A summary of key benefits of the proposed investigation;
• A summary of any available patient preference information;
• An assessment of uncertainty and why that uncertainty is acceptable; and
• A summation of how the elements justify the decision to proceed with the trial.

The FDA puts a strong emphasis on patient preference, which has been the focus of an ongoing initiative. The FDA has issued draft guidance highlighting the main factors to consider when collecting patient preference information to back PMAs, HDE applications and de novo requests (IDDM, May 15).

Read the draft guidance at www.fdanews.com/06-29-15-ide.pdf. — Elizabeth Hollis