510(k)/EUA/LTD

Are you working toward FDA 510(k), EUA or LDT? Knowing the avenue for submission can be challenging, but we are here every step of the way and work closely with you through the process.

DevLab bio is committed to supporting the development of your molecular or immunoassay and supporting regulatory submission with both 510(k) and Emergency Use Authorization (EUA) through the Federal Drug Administration (FDA) and with Laboratory Developed Test (LDT) development.

We provide validation support to meet Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA) standards. We create and develop all documents and validation procedures based on CLSI guidelines.

Contact us today to discuss your FDA 510(k), EUA or LDT assay project goals.

  • Perform all necessary Development Testing.
  • Prepare all Standard Operating Procedures (SOP)
  • Develop all necessary Protocols for your FDA 510(k), EUA or LDT assay.
  • Generate Data, Assist with validation, or Assist with Technology
  • Transfer to your Laboratory depending on your regulatory path
  • Prepare Submissions and correspondence with regulatory organization as necessary depending on your regulatory path
  • Clinical Trial Support utilizing partners

Next Steps to FDA 510(K)or EUA

Whether you are working toward an FDA 510(k) or EUA submission, we look forward to learning more about your FDA 510(k), EUA or LDT project and have the experience to help you reach your goal. Reach out today to begin your consultation. During our initial discovery call we will gain an understanding of your assay and specific requirements needed. There may be a series of initial calls as we dive into your project details to gather necessary information. Once we have a plan, we prepare a Statement of Work (SOW) along with a cost and timeline estimates. Once approved by you, we begin work on your project. During project development, we provide you with updates.

During the various steps along the development, submission process and post-submission FDA response, we work closely with your FDA Consultant. If you do not have an FDA Consultant or need additional support, we can assist you with this component through one of our partnerships.

Ready to learn more about the FDA submission process for your FDA 510(k) EUA or LDT assay?