On November 13, CAP leaders met with officials from the Food and Drug Administration (FDA) to ask clarifying questions about the FDA’s proposed regulation of laboratory-developed tests (LDTs) and how these rules would affect laboratories and patients. The CAP is in the process of drafting its comments and sought clarification on the proposal to inform its comments, due to the FDA by a December 4 submission deadline.

The meeting with the FDA was led by CAP President Donald S. Karcher, MD, FCAP; Immediate-Past President Emily E. Volk, MD, FCAP; Chair of the Council on Scientific Affairs Bradley S. Karon, MD, PhD, FCAP; Chair of the Council on Government and Professional Affairs (CGPA) A. Joe Saad, MD, FCAP; and former CGPA Chair Jonathan L. Myles, MD, FCAP.

“The CAP is actively reviewing the FDA proposed rulemaking on LDTs and drafting comments that align with our principles for regulatory oversight,” Dr. Karcher said. “Ultimately, we are seeking a balanced approach to oversight that enhances patient safety, allows innovation to continue, and maintains quality laboratory testing without creating significant regulatory burdens on pathologists and their laboratories.”

The FDA released the proposed rulemaking for LDTs on September 29. The CAP has serious concerns regarding several provisions in the proposed regulation and the CAP will call on the FDA to make significant changes to the proposal. During the November 13 meeting, the CAP asked questions about exemptions for manual tests, the FDA’s risk classification system and how tests can be down-classified by risk tier, the FDA’s existing regulatory framework for in vitro diagnostics, and labeling requirements.

Immediately after the proposed rulemaking’s release, the CAP was first to request that the FDA give stakeholders 120 days to review the proposal due to its complexity and implications for laboratory testing. On October 30, the FDA said it would proceed with the standard 60-day comment period.

During the meeting, the CAP asked the FDA if it would reconsider the decision given the amount of uncertainty over the proposed rule in the laboratory community. The FDA confirmed that the deadline to submit comments would not change. After review of the comments, the FDA will move forward with work on finalizing the regulation.