On May 6th, 2024, the FDA released a pivotal document titled “Final Rule Medical Devices; Laboratory Developed Tests,” marking a transformative moment for the medical device sector. On July 5th, a turning point was achieved since this Final Rule officially came into play.
Defining LDT: A Laboratory Developed Test (LDT) is considered an IVD that is designed, manufactured, and used within a single laboratory.
The FDA has refined its regulations to clarify that LDTs are considered devices under the FD&C Act. This includes scenarios where the IVD’s manufacturer is a laboratory.
Key Takeaways from the Final Rule:
Phaseout Policy: Spanning over 4 years, the policy is structured into 5 distinct stages:
- Stage 1 (Q2 2025): Adherence to Medical Device Reporting (MDR), correction/removal reporting, and Quality System (QS) requirements (§ 820.198).
- Stage 2 (Q2 2026): Compliance with registration/listing, labelling, and investigational use prerequisites.
- Stage 3 (Q2 2027): Fulfilment of QS requirements (Part 820, except § 820.198).
- Stage 4 (Q4 2027): Premarket review adherence for high-risk IVDs (Class III/licensed under section 351).
- Stage 5 (Q2 2028): Premarket review adherence for moderate and low-risk IVDs.
Scope of Application (section V -Phaseout Policy A.1):
The policy is applicable to IVDs produced and offered as LDTs by laboratories certified under CLIA for high complexity testing and used within such laboratories, even if these IVDs do not align with the FDA’s traditional definition of an LDT (i.e., designed, manufactured, and used within a single laboratory).
Have a look at the final rule: Medical Devices; Laboratory Developed Tests
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