The FDA’s rule reclassifying laboratory developed tests (LDTs) as medical devices was recently vacated by a federal court, but the story is far from over. With potential appeals on the horizon and long-term oversight of LDTs still under discussion, diagnostic developers and clinical labs must remain informed and ready.
This white paper offers timely insights into the original rule, what it aimed to change, and what you should consider in case regulatory enforcement resumes.
Download it now to explore:
- What the now-vacated LDT rule proposed and what may still be on the table
- Key compliance milestones and how you were expected to prepare
- How CLIA and FDA oversight differ (and why understanding both still matters)
- Strategic considerations for long-term quality, audit readiness, and risk mitigation
- Why you should continue evaluating your portfolios in anticipation of future change
When you need to navigate uncertain regulatory changes, It Takes Avania.