Anonymous - Comment

We recommend streamlining the annual IDE report requirements to focus on the reporting of safety information only, rather than both safety and effectiveness. The annual IDE report is submitted to the device review branch and other study related information (eg, protocol compliance, device accountability, etc.) are records that can be/are reviewed during FDA clinical site GCP compliance inspections. This information is also reviewed at the time of the premarket application. The safety data is the element of the IDE study that FDA may be expected to have the most concern about during the conduct of a clinical trial. Effectiveness data (in addition to safety) is closely reviewed at the time the premarket application is submitted for review. This would allow the Agency to focus their resources on the assessment of the safety data reported, and industry to focus reporting on this most critical component. The annual report could present the data in the same format as it is expected to be presented at the time of the premarket application (with guidance from the Agency on the table shells format to be used). This would also streamline the compilation of the data at premarket application time since the format/presentation expectation would have already been defined and only final data would be presented. Other basic study information could also continue to be presented (as it is currently), such as enrollment status, follow-up compliance, and site listing.