FDA Submission Assistance

We provide our partners in the biomedical manufacturing industry with a spectrum of laboratory services to assist in the preparation of products for timely, complete, and intelligently-supported FDA submissions. Our team performs both the correlation and comparative studies to gather the data necessary to submit. We offer support for: 

  • 510(k) Clearance
  • Premarket Approval (PMA)
  • De Novo Approval

Whether you are building research support for a new supplement or starting the approval process for a new medical device, our partnerships with manufacturers are highly customized. We have over a decade of experience in offering personalized support for a wide range of research analyte categories, including, but not limited to, autoimmune conditions, biogenic amines and neurology, bone and mineral metabolism, brain disorders and neuroscience, cardiovascular markers, cytokines and cell signaling, diabetes and obesity, endocrinology and hormones, gastroenterology, immunology, infectious diseases, and oncology.

From Protocol to Implementation

You’ve crafted your study protocol. Now you need to line up your research facility services to implement it

  • University-Based Studies
  • Private Sector Research
  • Beta-Site Testing, Pre-Clinical Trials, or
  • Clinical Trials
  • Experience in Broad Analyte Categories

By Analyte Laboratory

You’ve crafted your study protocol. Now you need to line up your research facility services to implement it

  • University-Based Studies
  • Private Sector Research
  • Beta-Site Testing, Pre-Clinical Trials, or Clinical Trials
  • Experience in Broad Analyte Categories

Customized full-service research
& diagnostic testing services

We help decrease your time to market.

Our team prides itself on providing high-quality testing services and support to ensure projects are completed efficiently. Our testing services generate the accurate and timely data you need to complete your validation on schedule, including applicable performance verification and correlation studies relevant to the FDA submission process. 

At KMI Diagnostics, we can adapt to your team’s changing needs and respond quickly to new requests. Our results are also accompanied by raw data and QC assessment that illustrate our accuracy, precision, and attention to detail. 

The quality of our research support services is validated by our certified regulatory compliance, giving you the confidence to submit your hard work for FDA approval. 

25%

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FDA Partner Case Study

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Hear From Our Partners

“Thank you for your exceptional customer service every step of the way. We were very pleased with your communication, dedication, and knowledge of methodology, and we are excited about the comprehensive results you provided us with.”

E Skornyakov,
Washington State University

“KMI Diagnostics provides an excellent service with a faster than expected turn-around time. Their professionalism and attentiveness to detail are unparalleled. It is always a pleasure to work with them and I would recommend them to anyone seeking replicable data for publication.”

A. Heuerman,
Loma Linda University

“Your services are always fast, efficient, and accurate along with friendly customer service! Thanks for the great experience!”

L.Farfel,
Harvard University

Personalized FDA submission support

Start preparing for your FDA submission.