IDEs play a pivotal role in clinical studies as certain trials require an IDE to be granted before they can begin. Knowing if you'll need an IDE for your investigational device is critical to your successful journey towards market approval.
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Hello. Grace, here from the team at Proxima Clinical Research.
Today, we're diving into an important topic for medical device developers: the Investigational Device Exemption or IDE. So what exactly is an IDE?
An Investigational Device Exemption is a regulatory status granted by the FDA. It allows researchers to conduct clinical investigations on medical devices that have not yet received FDA approval
in order to collect data on safety and effectiveness. This is important because the data collected during clinical investigations plays a key role in the FDA's assessment to determine whether the device can be approved or cleared.
In other words, without an IDE the clinical study cannot proceed, which effectively ends the investigational device's journey to market approval before it begins. However, not every device is required to submit an IDE. If your device study is determined to be a nonsignificant risk to patients by the Institutional Review Board or IRB, then an IDE is not necessary. Make note: having a skilled clinical team is crucial in determining the necessity of an IDE. To gain IDE approval,
a sponsor or manufacturer must properly fill out an IDE application. The application should provide information about the investigational device, including its design, manufacturing process and intended use. A clinical investigation protocol that outlines study objectives, methodology, patient population, and end points should also be included. An IDE application can be considered approved 30 days after it has been reviewed by the FDA unless otherwise indicated.
FDA may inform the sponsor of approval approval with conditions or disapproval prior to 30 calendar days from the date of receipt. Once IDE approval is granted, the sponsor or manufacturer may proceed with the clinical investigation. The key to a successful IDE submission and investigational study depends on the expertise of a knowledgeable clinical management team at Proxima we are here to support you at every step of the process.
Discover how our team can assist you in achieving your research goals by visiting us at proximacro.com