WASHINGTON – 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
• Labeling
The continuation of enforcement discretion policy in these areas would contribute significantly to the continued advancement of medicine and clinical care for patients, the CAP said. The CAP also made several recommendations to the FDA, including a call to convene public hearings to determine test risk classification and solicit input on an ongoing basis to advise officials on appropriately classifying tests. The FDA should also conduct comprehensive educational campaigns for laboratories on new requirements before enforcing adherence to new rules. Finally, the CAP strongly urged the FDA to provide more opportunities for public and stakeholder input before finalizing the proposed rule and proceeding with its subsequent phases.