The Investigational Device Exemption (IDE) application is a critical step for medical device developers who wish to conduct clinical trials in the United States. Understanding the IDE process is essential, as it allows a device to be used in a clinical study to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to the FDA. This process is designed to ensure that the proposed study is scientifically valid and ethically conducted and provides sufficient data to justify the marketing approval.
Navigating the Investigational Device Exemption (IDE) Submission Process
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