The U.S. FDA has finalized its rule on Laboratory Developed Tests (LDTs), subjecting LDTs to regulatory requirements similar to other in vitro diagnostic (IVD) products. Compliance will be implemented through a structured, multi-year timeline, with Phase I set to begin on May 6, 2025.
Quasar’s Commitment to Compliance
At Quasar, we are proactively implementing Phase I of FDA LDT compliance in-house in February 2025 as part of our beta testing initiative. This phase will focus on Medical Device Reporting (MDR), Correction and Removal Reporting, and Complaint Handling Procedures in alignment with the FDA’s first-stage requirements.
What This Means for Our Clients
- Ensuring Compliance – Quasar is committed to meeting regulatory requirements while continuing to provide high-quality solutions.
- Beta Testing Initiative – Our internal validation will ensure smooth implementation of compliance measures before broader adoption.
- Industry Leadership –We are actively monitoring regulatory updates, including potential changes under the current administration, which may impact LDT oversight, enforcement discretion, and compliance timelines. Legislative challenges may lead to modifications in implementation, and we are committed to adapting swiftly to any new requirements
Need Assistance with Implementation?
If your lab is preparing for FDA LDT compliance, Quasar is here to help. Our team is available to provide guidance, support, and insights to ensure a smooth transition.
📩 Contact Us to discuss how we can assist with your implementation strategy and compliance needs.