FDA Guidance – Decisions for IDE Clinical Investigations (Draft)

* Minor inadequacies regarding definitions associated with the safety endpoint

* Statistical questions regarding the proposal for an interim analysis

Based on the first two concerns, FDA disapproves the study. The deficiencies provided in FDA’s letter articulate each of FDA’s four concerns, specifically noting which deficiencies were the basis for disapproval.

In response to FDA’s letter, the sponsor submits an amendment to the IDE that includes additional test data and a modified clinical protocol. The amendment specifically responds to each deficiency that FDA identified in its letter. FDA’s review of the amendment does not identify any issues that preclude the sponsor from initiating the study. FDA determines that the durability test data that were provided strongly suggest good long-term performance of the device and are sufficient to support study of the device in a small group of subjects. However, the data are not adequate to fully address the identified deficiency and longer term non-clinical durability testing should be conducted before the entire study cohort is exposed to the risks of the study. FDA also identifies some minor outstanding concerns with other clarifications and modifications made in response to the deficiencies that FDA identified.

FDA issues a staged approval with conditions letter that allows the sponsor to begin enrollment in the study, for up to 50 subjects, on the condition that the sponsor addresses the issues identified in FDA’s letter within 45 days. One of the outstanding issues conveyed to the sponsor is a request that the sponsor conduct longer term durability testing concurrent to enrollment in the study and that the response to FDA’s approval with conditions letter include a detailed commitment to conduct this testing.