Investigational Device Exemption (IDE) 19:32 Aug 24, 2008
The FDA initially introduced the Pre-IDE process as a means of informal interaction to facilitate a clearer understanding of the Agency’s expectations for the design of medical device clinical trial and/or analytical testing before the submission of a formal Investigational Device Exemption (IDE) necessary to conduct a medical device clinical trial.
The process has since evolved into a means for gaining feedback in several other areas, most notably for non-significant risk, exempt or post-market studies which do not require an IDE submission, but which will generate data to support an eventual marketing submission.
Pre-IDE meetings are also especially beneficial for medical device manufacturers who have not had previous contact with the FDA and whose device utilizes new technologies or involves new uses of existing technologies. This early interaction with the FDA helps clients to gain a clearer understanding of relevant medical device regulations, requirements, and guidance documents. It is provides an excellent means to obtain the FDA’s input and guidance regarding the appropriate regulatory pathway, the proper approach to refine and/or define clinical data and statistical analyses, and to answer critical questions related to clinical study design.
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peer agreement (net): +3