Medical Device Investigational Device Exemptions (IDE) for US FDA

Deep Expertise in FDA Compliance

If a medical device maker is developing a new product or pursuing a new indication for an existing device and has determined that a clinical investigation is required; the first consideration is whether the proposed investigation is a ‘significant’ or ‘non-significant’ risk to the patients. FDA approval of an Investigational Device Exemption (IDE) is required for US human study of a significant risk device which does not have marketing authorization for the indication being studied, or a new use of an approved device. Initiation of the study requires approval by Institutional Review Board (IRB).

NAMSA can support companies wishing to submit an IDE with the following processes:

• Initiating a Pre-Submission to FDA to help with the determination of significant risk vs. non-significant risk clinical study
• Generating a Pre-Submission to FDA to derisk the clinical study by providing a Clinical Study Protocol prior to submitting in an official IDE
• Compilation of IDE documents including the cover letter, study protocol, informed consent forms, benefit/risk analysis and information about the device and intended use and more
• Review of proposed labeling and IFU
• Facilitation and management of required clinical studies
• Preparing the submission to meet FDA expectations

We Understand the Clinical and Testing Data the FDA Expects to See

Unlike most regulatory consultancies, NAMSA is also a leading medical device clinical research and testing organization. We provide comprehensive IDE submission support, guiding you from the initial stages with robust testing approaches. If the FDA cites deficiencies in your IDE submission related to testing data, we can assist by analyzing FDA comments, reviewing raw data, reports, and competitor studies, assessing the adequacy of existing data, and recommending additional tests if necessary. Our goal is to ensure your IDE submission is strong and meets all regulatory requirements, minimizing delays and facilitating a smoother approval process. See our complete offering of testing services here.

Let NAMSA Conduct Your Clinical Trials

In addition to our experienced regulatory team of FDA experts, NAMSA is one of the world’s leading clinical research organizations focused on medical devices and IVD’s. We can help you in all aspects of trial management, biostatistics, data management and much more. See our complete offering of clinical services here.