Two regulatory earthquakes just reshaped diagnostics strategy. The FDA vacated its LDT rule. IVDR’s deadlines just became fixed. Neither is a footnote.
Most teams assume the bottleneck in a diagnostics program is the bench. It rarely is. Programs stall in study design, in FDA framework negotiations, and in the IVDR performance-evaluation transition, not in assay development.
Inside, Subo Perampalam, PhD and Angela Johnson, PhD, RAC, PMP break down:
- How to design one master program that earns many claims, instead of running a new study for every new claim
- The cutoff-locking discipline reviewers ask about directly, and how to get it right the first time
- What the LDT rule vacatur actually changed, and what it didn’t
- How to sequence US and EU submissions from a single body of evidence
- Where human factors and cybersecurity quietly decide your timeline
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