What action is the FDA NOT required to take upon receiving an IDE application?

The action that the FDA is not required to take upon receiving an Investigational Device Exemption (IDE) application is the requirement to review and approve it within five business days. In reality, the FDA’s process for reviewing IDE applications can take longer, often depending on the complexity of the submission and any potential issues that may arise during the review. The FDA may take substantial time to ensure that the IDE meets regulatory requirements and is safe for the intended clinical trials.

Conversely, the FDA is obligated to notify the sponsor of any issues with their application, provide written justification for any denial of the IDE, and respond with official acknowledgment of receipt of the application. These requirements are in place to ensure transparency and communication between the FDA and the sponsor throughout the review process, promoting patient safety and regulatory compliance.