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IDE policy allowing clinical study extensions implemented across ODE.

This article was originally published in The Gray Sheet

Executive Summary

IDE SUPPLEMENTS FOR CLINICAL STUDY EXTENSION UNTIL PRODUCT APPROVAL are being considered uniformly across all divisions of FDA's Office of Device Evaluation through a recent memo sent by ODE Director Susan Alpert to reviewers. The memo provides general principles that should be used in determining whether to follow ODE's general policy of allowing continued availability of investigational devices between completion of a clinical study and product clearance. Alpert issued the memo because some ODE divisions were not implementing the policy out of concern that devices they review require longer follow-up times to demonstrate safety and effectiveness and therefore should not get expanded protocols.
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