In a final rule for regulation of LDTs, on April 29, 2024, FDA announced it would not require FDA review for LDTs reviewed and approved by New York State CLEP.
See the whole 175,000 word rule for yourself, here.
Below, find a Chat GPT summary of key pages discussed NYS CLEP below. (Pages 43-49,302-307). Remember this is an AI-driven interpretation about what the FDA itself writes, it is not a critique of the FDA's position.
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The New York State Department of Health Clinical Laboratory Evaluation Program (NYS CLEP) plays a significant role in the regulation and oversight of Laboratory Developed Tests (LDTs). The FDA acknowledges that NYS CLEP has established a robust system for evaluating the analytical and clinical validity of high and moderate risk LDTs. This system is designed to mitigate the risk of harm from inaccurate and unreliable LDTs. Based on this, the FDA intends to exercise enforcement discretion, meaning that it will not enforce certain premarket review requirements for LDTs that have either been fully approved by NYS CLEP or received conditional approval.
Key Aspects of NYS CLEP's Oversight:
High Risk LDTs: Require full technical review and approval before they can be used on specimens from New York State.
Moderate Risk LDTs: Also require full technical review and may receive conditional approval, allowing the test to be offered while the review is still pending.
Review Process: Includes an evaluation of the LDT's analytical and clinical validity, ensuring that the test is both accurate and reliable.
Conditional Approval: Allows tests to be used while under review. If a test ultimately does not receive full approval, it is removed from the enforcement discretion policy.
Exemptions: Laboratories with proven method validation can request exemptions from full technical documentation for future tests using the same methodology.
FDA's Enforcement Discretion:
The FDA's decision to not enforce premarket review requirements for NYS CLEP-approved LDTs allows the FDA to allocate its resources more effectively to other oversight activities. This policy applies regardless of whether the specimen comes from New York State or elsewhere, but only to the version of the LDT that is approved by NYS CLEP.
Impact and Implications:
Efficiency: By recognizing NYS CLEP’s review process, the FDA avoids duplicative efforts and reduces the regulatory burden on laboratories.
Public Health: This policy is expected to maintain high standards for LDT safety and effectiveness, as NYS CLEP’s review process aligns closely with the FDA’s standards.
Phase-out of General Enforcement Discretion: While premarket review requirements may be relaxed for NYS CLEP-approved LDTs, other FDA requirements such as adverse event reporting, registration, and listing will still be enforced according to the phased timeline established by the FDA.
Concerns and Considerations:
Some stakeholders have expressed concerns that leveraging NYS CLEP's program should not replace FDA regulation entirely. They emphasize that while NYS CLEP’s oversight is robust, FDA’s regulatory framework includes broader and potentially more stringent standards. The FDA acknowledges these concerns and clarifies that this policy is a form of enforcement discretion, not a complete handover of regulatory authority.
In summary, the FDA’s approach to utilizing NYS CLEP’s established programs for certain LDTs reflects a strategic use of regulatory resources to ensure safety and effectiveness while minimizing unnecessary duplication of regulatory efforts. This decision underscores the FDA's commitment to a risk-based regulatory framework that protects public health without stifling innovation in laboratory testing.
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