FDA issues long-awaited update to Pre-IDE guidance: New draft guidance on Pre-Submission program for medical devices released
26 July 2012Medical Device Alert
On 13 July 2012, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued a highly anticipated draft guidance document intended to eventually supersede the 25 March 1999, Blue Book Memorandum Pre-IDE Program: Issues and Answers. While the Pre-IDE process was originally developed for sponsors to obtain feedback on future Investigational Device Exemption (IDE) applications, over time, these meetings evolved to allow for feedback on other types of device applications, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, and Premarket Notification (510(k)) notices. The new draft guidance, Medical Devices: The Pre-Submission Program and Meetings with FDA Staff, updates the pre-IDE program to officially provide what will be called pre-submission (Pre-Sub) meetings for applicants to receive feedback on future IDE, PMA, HDE, and 510(k) submissions, as well as the design of IDE-exempt, NSR and OUS studies. This guidance largely reflects how FDA has been handling pre-submission meetings over the last several years.