Yes. Both CDRH and CBER have developed processes that allow sponsors to
obtain early FDA input and review of proposed studies by submission of the
protocol and other study materials in the form of a “pre-IDE” document and/or a
discussion in the form of a “pre-IDE” meeting. While we refer to this early input
as a “pre-IDE” process, it is also available for studies that are exempt from most
IDE requirements under 21 CFR 812.2(c)(3) or that will be conducted under the
abbreviated IDE regulations for NSR studies (21 CFR 812.2). FDA encourages
use of the pre-IDE submission and/or meeting whenever the sponsor desires early
feedback for clinical studies, particularly those for novel or high risk (Class III)
devices. If you (the sponsor) are interested in submitting a pre-IDE, we
recommend that you contact the Division that will review your device before you
initiate your studies (See Introduction, Section II, question # 4 of this guidance).
Use of the pre-IDE process does not obligate you in any way to future submission
of an IDE. FDA also encourages continued communication throughout the course
of the study. This communication can be in the form of an informational
meeting/telephone call or status reports to the pre-IDE file.
