CDRH Plans New Guidance to Help Sponsors With Pre-IDE Process

Sponsors may soon have new guidance to help them prepare for pre-investigational device exemption (IDE) meetings with CDRH. A key element of the guidance is a recommendation that sponsors submit summaries at the meeting rather than clinical data, Carolyn Neuland, chief of CDRH’s Gastroenterology and Renal Devices Branch, said. Pre-IDE meetings are usually conducted early in the clinical trial planning process for a device to give sponsors a sense of applicable regulations and agency expectations.
Devices & Diagnostics Letter