US In Vitro Diagnostics Devices

Navigating the FDA takes experience.
Fang can help.

The IVD market in the US is valued between $40 – $83.3 billion and is growing rapidly with pandemics and an increasingly older population driving demand.

Whether your product is a reagent, instrument or software, the Fang Consulting team has a solid understanding of in vitro diagnostic devices and can assist your team prepare for a submission.

US Services

  • Establishing General Controls
  • Meeting CLIA standards
  • 510(k) Submissions
    • Classification review
    • General Purpose Reagent (GSP) determination and classification
    • Analyte Specific Reagent (ASR) determination and classification
    • Type of 510(k) needed: Traditional, Special or Abbreviated
  • De Novo submissions
  • Q-Submission meetings
    • Pre-submissions (Pre-subs)
      • Testing review
      • Predicate or reference method review
      • New device review
    • Submission Issue Requests (SIRs)
    • Feedback for specific questions
    • PowerPoint presentation
    • Team rehearsals
  • Labeling review
  • Establishment Registration & Device Listing
  • Current Good Manufacturing Practices (cGMPs) and Quality System (QS) questions
  • Medical Device Reporting (MDR)