Nov 14, 2011

The US Food and Drug Administration is proposing a new policy for Investigational Device Exemption (IDE) applications for early feasibility studies of high-risk medical devices, according to new guidance from the agency.

The guidance covers early feasibility clinical studies, which are limited clinical investigations conducted early in device development for specific indications, and first in human (FIH) studies, in which devices for specific indications are evaluated for the first time using human test subjects.

New FDA policies regarding early feasibility and FIH studies included in the guidance would allow agency approval of IDE applications for such studies based on less non-clinical data than would be required for traditional feasibility studies. The guidance would also enable timelier device and clinical protocol changes during early feasibility studies but still require compliance with 21 CFR Part 812 IDE regulations.

Reports of Prior Investigations

The guidance lays out specific requirements for 21 CFR Part 812 requirements targeting Reports of Prior Investigations for early feasibility studies. Reports of Prior Investigations should include sections on background, executive summary and detailed reports, as well as information to justify clinical investigation of a medical device.

Information provided in Reports of Prior Investigation should support expectations of acceptable clinical use of a device, and that the device in question functions as the manufacturer intended. Reports should also cover basic device safety issues as well as catastrophic failure modes and risk mitigation processes.

Investigational Plans

Requirements in 21 CFR Part 812 also entail Investigational Plans in order to clarify that early feasibility studies are not being conducted to collect data to support device marketing applications. Components of an Investigational Plan should include risk analysis and mitigation, a clinical protocol, human subject protection measures and monitoring procedures.

Iterations during Early Feasibility Studies

Finally, the guidance emphasizes the need to discuss with the FDA whenever changes need to be made to investigational plans during the pre-IDE process. The guidance would set a new policy to allow more types of modifications to be made to devices and clinical protocols during early feasibility studies using five-day notices without prior FDA approval.

For changes that would require prior FDA approval, the guidance introduces contingent approval—permitting changes based upon acceptable non-clinical test results without requiring additional FDA review—and interactive review, which would boost communication between applicants and the agency during 30-day review timeframes for early feasibility IDE supplements. 


  • Stewart Eisenhart