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IDE REVIEW LEVELS WILL BE DELINEATED ACCORDING TO NATURE OF STUDY

This article was originally published in The Gray Sheet

Executive Summary

IDE REVIEW LEVELS WILL BE DELINEATED ACCORDING TO NATURE OF STUDY in a policy statement on investigational device exemptions under development by FDA's Office of Device Evaluation. The policy will provide reviewers and sponsors with guidance on the level of review that various types of IDE applications should receive by ODE staff. For example, the policy will likely stipulate that FDA should have less stringent requirements for physician-sponsored IDE studies that are not intended to lead to a marketing application than for company-sponsored studies designed to support a marketing application. Other areas that may be addressed in the policy include how reviewers should deal with changes in a study. The policy will not break new ground; it essentially will codify ongoing practice in the IDE review program. The agency expects, however, that the existence of a clear policy statement should help FDAers review applications more efficiently and should make the review process more predictable for sponsors. The policy is being developed in conjunction with an overall review of the IDE program initiated at the request of ODE Acting Director Susan Alpert. One goal of the effort is to reduce the average number of review cycles for an IDE to below two from the current average of 2.7. A review cycle is the number of times a sponsor submits information to FDA, including the initial application. FDA also is planning to develop additional guidances in the IDE area. Some of the guidances will address IDE policy applicable to all types of devices while others will be specific to certain types of products.
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