FDA Submissions
Navigate the regulatory process with experienced experts
Regulatory Expertise to Help Get to Market
MRIGlobal utilizes its regulatory expertise to develop tailored strategies and guide in vitro diagnostics and medical devices through complex FDA pathways, including 510(k) submissions, Emergency Use Authorizations (EUAs), de novos, and PMAs. We support products that meet scientific, quality, and regulatory standards while generating the evidence needed to demonstrate safety and effectiveness. This expertise can help streamline the submission process, reduce regulatory risk, and accelerate readiness for commercialization of critical IVD technologies.
Regulatory Expertise to Support Market Access
FDA Regulatory Strategy and Planning
Develop tailored regulatory strategies for IVDs and medical devices pursuing FDA 510(k), EUA, de novo, PMA, and Q-submissions.
Regulatory Risk Analysis and Mitigation
Identify potential regulatory challenges early and implement strategies to reduce review delays and submission risks.
Submission Preparation
Prepare and organize regulatory documentation to demonstrate product safety, performance, and clinical utility.
Analytical and Clinical Evidence Development
Compile and present the clinical and analytical data needed to support FDA submissions and regulatory decision-making.
Proven Track Record
Supported regulatory submissions for more than 50 different IVDs for influenza, SARS-CoV-2, Hep C, and other diseases since 2019.
Latest from the blog
-
Consumer Product Testing and Evaluation Expertise
As a contract research organization (CRO) with a history of important breakthroughs in disease diagnostics, pharmaceutical science, and medical research, we are often tasked with addressing challenges at the forefront of scientific research – including consumer product testing.Because no two challenges are the same, our role is to adapt and seek solutions based on our […]
FDA Submissions Methods & Materials Testing & Evaluation -
New Laboratory and Instrumentation Supports 510(k) Submissions for FDA
Through the COVID-19 pandemic, we assisted customers with their work to move diagnostic devices through the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) process, enabling temporary market access. Today, those same customers are interested in achieving permanent market access through the FDA’s 510(k) approval process. Per FDA, “A 510(k) is a premarket submission […]
Assay & Method Development FDA Submissions Verification & Validation -
MRIGlobal is Your Key Partner in Disease Diagnostic Development and FDA Filing
MRIGlobal offers a broad portfolio of infectious disease diagnostic capabilities across the development lifecycle, from initial feasibility and development studies, to testing, validation and verification, to clinical comparator testing and preparation for FDA filing. We bring the needed experience to partner with organizations seeking to improve and innovate in the diagnostic space, making us an […]
FDA Submissions In Vitro Diagnostics Solutions RUO to IVD Product Development
