🔍 Quasar’s Perspective on the FDA’s Phased LDT Framework
At Quasar Instruments, we’ve been closely following the FDA’s proposed framework for LDTs. While the formal rule has been withdrawn, we believe its structure outlined important principles — many of which align with our internal quality approach.
Here’s how we view each phase, and how we’re incorporating them into our practices:
Phase 1 – Monitor and Document. The focus here was observational: monitor performance, document findings, and identify potential issues. While formal FDA reporting was not required in this phase, we believe this kind of surveillance is crucial. We’re actively implementing internal monitoring systems that provide early insights into test performance.
Phase 2 – Scientific and Clinical Viability. This phase addressed labeling and clinical claims. At Quasar, we take this seriously — ensuring our products are not only scientifically sound but also clinically viable and defensible. Ongoing validation and clear documentation support the safety and utility of our offerings.
Phase 3 – Robust Quality Control. Phase 3 emphasized quality systems — and we fully agree. We view validation as more than a checkbox; it’s a system health check, a proactive way to detect early signs of drift or performance issues. Our goal is to develop and maintain a comprehensive QC program that meets — and often exceeds — traditional device standards.
🧭 Where We Stand Now
We’re actively evolving our Phase 1 product, with efforts already underway to meet the spirit of Phase 2 and 3. Even though this specific regulation was withdrawn, we believe parts of it may re-emerge in future policy — and we’re building for that future now.
We 100% support the FDA’s intent. While the attempt to fit LDTs into a traditional device framework was imperfect, the underlying push for rigor, transparency, and accountability in lab-developed testing is something we deeply believe in.