Our LDT Consulting Services
Celegence specializes in providing expert consulting services for organizations interested in developing Laboratory Developed Tests (LDTs). Our consulting team offers comprehensive support and guidance throughout the development process, ensuring compliance with regulatory standards and delivering accurate and reliable diagnostic solutions.
Need Help with FDA LDT?
Why Choose Celegence for Your LDT Development Needs?
Regulatory Guidance
Celegence provides comprehensive guidance on FDA and CLIA standards, ensuring compliance and reliability in LDT development
Strategic Planning
We help clients develop strategic plans for LDT development, ensuring alignment with their overall healthcare objectives
Technical Expertise
Our team of experienced professionals offers technical expertise in LDT development, from assay design to validation
Market Analysis
We conduct thorough market analysis to identify opportunities and challenges in the LDT market, guiding clients towards successful product launches
LDT Timeline
Stage 1
By May 6, 2025, labs must update their QMS to include adverse event reporting, corrections and removals reporting, and complaint file maintenance.
Stage 2
By May 6, 2026, labs must complete registration and device listing for their LDT, and update QMS to include labeling and investigational use requirements.
Stage 3
By May 6, 2027, labs must update their QMS to meet remaining FDA Medical Device requirements, including design controls, purchasing controls, acceptance activities, CAPAs, and records.
Final Stage
Depending on the LDT’s risk classification, it must be submitted to the FDA by November 6, 2027, for PMA submissions or by November 6, 2028, for 510k or De Novo pathways.
Benefits of Partnering with Celegence
Join leading healthcare providers who trust Celegence as their preferred consulting partner for Laboratory Developed Tests.
Contact Us Today
From strategic planning to regulatory guidance, Celegence is your trusted partner for Laboratory Developed Tests (LDTs). Contact us today to learn how we can support your LDT development efficiently and cost-effectively.
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