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)