Pre-Decisional IDE Process Could Speed Approval of Clinical Trial Starts

The FDA is seeking industry input on a voluntary program aimed at getting devicemakers to engage with the agency early in the clinical trial design process. The pre-decisional IDE process, proposed in a draft guidance on FDA decisions for IDE clinical investigations, would allow sponsors to obtain timely feedback from FDA reviewers on near-final IDE applications and avoid potential stumbling blocks related to device or subject safety or study design.
Devices & Diagnostics Letter