Importance of FDA Pre-Submissions Before Your Clinical Study
MRIGlobal is here to act as your FDA consultant, helping navigate design control and more. Everything starts with an FDA pre-submission. This formal process solitics feedback from the FDA to make sure the proposed clinical studies sufficiently meet their standards.
The FDA pre-submission phase is vital: Without it you could spend a lot of money on studies that the FDA won’t consider for clearance.
Putting together the FDA pre-submission package
To get written feedback from the FDA, you can work with the MRIGlobal team to put together a pre-submission package. This is a regimented process that requires you to wait about three months to get feedback. After hearing from the FDA on the pre-submission materials, we can request a face-to-face meeting. (A face-to-face meeting may be needed for clarification on its points or to discuss any of its comments.)
A pre-submission can change the entire regulatory pathway a study must go through. You can go into the process expecting to secure an at-home claim for your device, only to have the FDA advise that it would be better to seek clearance for a clinical or professional setting.
Special factors for De Novo devices
When a device has no legally marketed devices of a similar type, but for which general and special controls are able to provide a reasonable assurance of safety and effectiveness, it is classified by the FDA as a De Novo device. These devices have no FDA cleared predicate tests, but MRIGlobal has extensive experience leading projects for De Novo devices. The pre-submission aspect of De Novo devices applies in much the same way, though many find the feedback incredibly valuable for their device(s).
There is no requirement in terms of the maturity or development of the device when you’re doing an FDA pre-submission. With a De Novo submission, you want to be able to ask a lot of questions very early into the process of developing your device. This will help create a solid foundation for the eventual granted status.
Our group of experts makes the process simple by condensing our vast experience with De Novo submissions and 510(k) submissions for you.
Communicate effectively during FDA pre-submissions
Deft maneuvering through the process of pre-submissions to the FDA requires thinking like both a lawyer and a scientist. Our job is to keep you from feeling intimidated by the breadth of the regulations that must be followed. MRIGlobal navigates the process and helps clients understand what questions they should be asking, what they should be thinking about, and more.
Develop your diagnostic product or design your studies with MRIGlobal
We are here for all of your diagnostic needs. Our CLIA-certified high complexity labs can perform reference testing. We can serve as a beta site to give usability feedback on a device or software that’s being tested, and we can help with research and development. If you have a high level idea but lack the technical expertise, we can bring your idea to fruition. Our Institutional Review Board is accredited to review studies involving human subjects to ensure their safety and welfare. We’re one of the most comprehensive research firms for FDA submissions.
Whether you are submitting to the FDA or regulatory agencies across the world, we can support you. From the biggest names in diagnostics to startups, we’ll make sure the process doesn’t overwhelm and that your diagnostic is submitted for clearance.