PHASE OUT OF MEDICAL DEVICE MANUFACTURING REGULATIONS !

FDA's Final Rule on Laboratory-Developed Tests (LDTs): The LDT Final Rule is now effective since July 5, 2024.This rule, announced in April 2024, marks a significant shift in the FDA's approach to LDTs. It establishes a risk-based framework for regulating LDTs, with higher-risk tests subject to more stringent oversight. This will likely impact labs by requiring them to comply with new regulations and potentially seek FDA approval for certain tests.FOUR-YEAR PHASEOUT APPROACH:

FDA is phasing out its blanket enforcement discretion policy for LDTs over the course of four years in five stages. At each stage, FDA expects LDTs to come into compliance with specific regulatory requirements:

• Stage 1: Compliance with requirements for medical device reporting (MDR), corrections and removals reporting, and complaint handling starting one year after Final Rule publication date

• Stage 2: Compliance with other regulatory requirements—including establishment registration, device listing, labeling, and investigational use—required starting two years after Final Rule publication date.

• Stage 3: Compliance with the quality system regulation (QSR), which sets forth the good manufacturing practices for medical devices, starting three years after Final Rule publication date

• Stage 4: Compliance with premarket review requirements for high-risk LDTs, starting three and a half years after Final Rule publication date

• Stage 5: Compliance with premarket review requirements for low and moderate-risk LDTs, starting four years after Final Rule publication date - original source Authors Michele L. Buenafe , Dennis C. Gucciardo (Washington, DC) https://www.morganlewis.com/pubs/2024/05/key-takeaways-from-fdas-final-rule-on-laboratory-developed-tests.  -for additional reading