FDA's Proposed Rule Regarding Laboratory-Developed Tests
Citing substantial undue regulatory burdens and costs on laboratories, the College of American Pathologists (CAP) called on the US Food and Drug Administration (FDA) to make significant changes to its proposed regulation of laboratory-developed tests (LDTs) in a letter to the FDA on December 4.
"As physician specialists in the diagnosis of disease, pathologists have a long history of delivering high-quality pathology and clinical laboratory services to patients," said CAP President Donald Karcher, MD, FCAP. "For more than a decade, the CAP has advocated for an LDT oversight framework that enhances patient safety, maintains quality laboratory testing, and promotes innovation without creating significant regulatory burdens on pathologists and laboratories. The FDA must strike the right balance of protecting the public without overburdening laboratories to the point where they can no longer offer highly accurate LDTs. The CAP and its members urge the FDA to ensure laboratories can meet any new requirements without interfering with patient care and stifling the innovation of future testing."
The proposed regulation would phase out the current enforcement discretion approach by the FDA for LDT oversight. The FDA would classify over the course of five years in vitro diagnostics (IVDs) offered as LDTs as Class I, II, or III medical devices depending on risk to patients.
In its comments to the FDA, the CAP recommended that the following categories of the proposed rulemaking should continue under the FDA’s enforcement discretion policies:
- Exempting tests offered prior to the rule’s enactment
- Forensic, Human Leukocyte Antigen (HLA), and manual tests
- LDTs developed and offered locally by a clinical laboratory
- Adverse events reporting
- Quality systems
- Corrective action and removal
First reported in the December 4, 2023 Advocacy Update.
Read the full comment letter.
Updated CLIA PT Regulations Set for January 1, 2025 Implementation
The final rule CMS–3355–F, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance, was published in the Federal Register on July 11, 2022. The revisions to PT requirements related to the addition and deletion of analytes or microbiology tests and updates to the criteria for acceptable performance and administrative processes for PT programs are effective on July 11, 2024, two years after the publication date of the final rule in the Federal Register.
While the final rule is effective July 11, 2024, per CMS directive, the implementation date for the laboratories and PT program providers for these revisions will be January 01, 2025, which is in alignment with its current process for PT program providers and PT enrollment.
As your partner in laboratory quality solutions, we wanted to reach out to you to make you aware of the implementation date of January 01, 2025, and will continue to provide guidance throughout 2024.