IRB & FDA Support | Center for Technology Transfer & Commercialization

MPSS can assess the regulatory requirements for your product, whether the goal is a clinical study or bringing the product to the market. We also collaborate with the Vanderbilt IRB, to support investigators with their IRB submission documentation and help with resolving any questions or concerns. MPSS is available to assist with review of any investigational product.MPSS is also well connected with the FDA, with whom we interact to get advice and guidance whenever needed. If you planning a clinical study and it will require an Investigational Device Exemption (IDE) submission with the FDA, MPSS can help with the initial pre-submission as well as guiding you through the IDE submission process.

If you are planning a clinical study or in the future taking the device to the US market, it is always advised to have early interaction with the IRB and/or FDA, as applicable. Please reach out to MPSS and we can support you and facilitate these interactions!

Individualized consultation on your submission documents
- Navigating the IRB and FDA process for your product development
- Informal communication and interaction with the FDA to get early input to regulatory strategies for your product
- Assist in device risk assessments to support and guide IRB and FDA documentation and communication for your product
- Provide guidance for pre-clinical data to support a clinical study application for your product
FDA pre-submission and IDE submission guidance and support
- Navigating the IRB and FDA process for your product development
- Informal communication and interaction with the FDA to get early input to regulatory strategies for your product
- Assist in device risk assessments to support and guide IRB and FDA documentation and communication for your product
- Provide guidance for pre-clinical data to support a clinical study application for your product
Guidance for using the Vanderbilt Quality Management System to meet FDA IDE requirements
Assist in identifying resources relative to your medical product within and outside Vanderbilt

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I have worked at VUMC since 2001 and am a clinician-scientist doing research involving medical devices. During this time, I have seen the medical device regulatory process evolve to the point that the regulatory burden often requires more effort than the actual research. Especially in academia, where resources are scarce, this regulatory burden can dissuade investigators from innovating, and I have witnessed firsthand investigators “throwing in the towel” out of frustration.
In the development of the MPSS program, Vanderbilt was on the forefront of recognizing this problem and mobilizing resources to help investigators navigate the regulatory pathways. For me, this has meant that MPSS has provided support and guidance while I navigate the FDA IDE process in very tangible ways including assistance in preparation and review of regulatory submissions. Without their input, I believe I would have abandoned my clinical translational project.
From my perspective, MPSS program should become a national standard for how academic institutions handle medical device innovation, experimentation, and ultimately, translation to routine clinical use.

Robert Labadie, MD, Ph.D

Professor and Director of Research
Department of Otolaryngology, Head and Neck Surgery