Is FDA willing to review and discuss a study protocol even if the study is exempt from most of the Part 812 requirements?
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 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 co
Related Questions
- What if I need a new study, additional investigator, protocol amendment or request for continuing review reviewed before the regularly scheduled Board meeting?
- What if I just submitted a request for continuation to the IRB or a new study protocol and it is in currently in the review process?
- Is FDA willing to review and discuss a study protocol even if the study is exempt from most of the Part 812 requirements?
