Consultants Specializing in Regulatory Affairs for FDA Compliance

IDE: Investigational Device Exemption

An investigational device exemption (IDE) allows the investigational device to be legally used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification (510K). Involved in this process is an approved clinical protocol, administrative monitoring plan, IRB approval, patient informed consent form, etc. in order for the manufacturer to gather the clinical information on humans to establish the safety and effectiveness data.

Smith Associates has assisted manufacturers in submitting IDEs that have included 10 year saline and gel-filled breast saline implant studies, testicular implants, warming cabinets, ADHD diagnostic blood tests and HTLV diagnostic tests.

    Our services include:

    • Clinical review for protocol bibliography
    • Protocol development
    • Case Report Forms
    • Administrative Plan
    • Study Data Management
    • Preparation and Submission of IDE to the appropriate reviewing branch

Whatever the route required for your company's medical product, Smith Associates is experienced in every aspect of the process and will assist you in addressing the mandatory IDE requirements.

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