Published On:
February 7, 2025
Countdown to Compliance: Are You Ready for the FDA’s LDT Deadline?
The clock is ticking! Mark your calendars for May 6, 2025 which is the date when Laboratory Developed Test (LDT) firms must meet Stage 1 compliance requirements. This is a critical milestone and need to ensure you’re fully prepared
Key Compliance Areas for LDT Firms:
- Medical Device Reporting (21 CFR 803): Stay on top of your reporting obligations.
- Corrections & Removals Reporting (21 CFR 806): Know when and how to act.
- Quality System (QS) Requirements for Complaint Files (21 CFR 820.198): Keep your quality management in check.
Are you ready to tackle these new regulations?
ECI’s team of global regulatory experts can guide you through the compliance landscape and ensure you meet the Stage 1 deadline with confidence. Contact us to get started today.
Learn more: FDA LDT Final Rule
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