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U.S. Department of Health and Human Services

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Investigational Device Exemption (IDE) - Pivotal IDE Description Summary Form

An investigational device exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data to support a Premarket Approval (PMA) application or a Premarket Notification (510[k]) submission to FDA. Data included in a PMA or 510(k) are often generated from a substantive, or pivotal, clinical trial conducted to support the safety and effectiveness of a medical device.

The Pivotal IDE Descriptive Summary form is completed by FDA reviewers as part of the IDE review process for pivotal trials to provide an accessible summary of the major trial design elements. This Summary serves as a tool to move FDA closer to our goal of rigorously-designed pivotal studies that will be better able to answer essential questions of safety and effectiveness during the review of marketing applications. The information in this Summary also assists FDA reviewers in maintaining consistency, where appropriate, across clinical trials for devices similar in design and/or intended use.

Under the CDRH Transparency Initiative, FDA is making available for the first time a sample copy of this form so that investigators and others are aware of the key elements of clinical trial design that FDA evaluates in a pivotal IDE application.

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Additional Information

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