medical

IVD Regulatory Consulting for FDA Submissions

Several FDA regulatory submission pathways are available for IVDs, but the right choice is not always clear. What is clear is that going down the wrong path can cost your company a lot of money and significantly delay your market launch. We can help you get it right the first time.

How Long Will It Take? How Much Will It Cost?

The two most asked questions by clients, and for good reason! Answering them requires an experienced technical development team conversant in your specific IVD technology, paired with the regulatory expertise of a team that has advised dozens of IVD clients on FDA submissions. Our IVD Solutions team offers expertise in analytical, clinical, and usability studies in support of FDA submissions.

We Help Find the Optimal Path to FDA Clearance

We have worked with hundreds of IVD manufacturers and a wide variety of diagnostic technologies, including Point of Care (POC) tests, Over the Counter (OTC) devices and sophisticated diagnostic systems. We provide a variety of services including study design, protocol writing, pre-submissions, subject enrollment, data analysis to complete report for FDA submission.

In some cases, FDA feedback on study risk determination, proposed clinical trial protocols or other issues may be needed prior to submission. If needed, we will coordinate a formal pre-submission (pre-sub) advisory meeting with FDA reviewers to address those questions. Getting on the same page with FDA early on is the best way to avoid a Refuse to Accept (RTA) letter or a lengthy Additional Information (AI) request.

We Can Assist with these Clinical and Regulatory Services

Regulatory

FDA Device Classification 

Submission Pathway Options

FDA Predicate Device Research

Dual 510(k) and CLIA Waiver 

FDA De Novo Submission

FDA EUA to 510(k) Transition

Design Control and Design History Files

 

Clinical & Usability

Claims Review

Intended Use / Indications for Use

Investigational Device Exemptions (IDE) 

Analytical Verification for 510(k)

Clinical & Stability Study Summary

Flex Studies

Usability Evaluation

In-House CRO Speeds Your Path to Approval

Our deep understanding of the clinical data needed to support specific types of IVD submissions allows us to design, develop and execute the most cost-effective study needed for a successful FDA 510(k), CLIA waiver, IDE or PMA submission.

Proven IVD Expertise, From Concept to Market