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- ICYMI: CAP Seeks 120-Day Comment Period for FDA Proposal on the Oversight of LDTs
On Friday, September 29, the CAP President Emily E. Volk, MD, MBA, FCAP, issued a statement following the release of the US Food and Drug Administration (FDA) proposed rulemaking on laboratory-developed tests (LDTs). Due to the complexity of the rule and implications for laboratory testing, the CAP is calling on the FDA to extend the comment period to at least 120 days to give stakeholders more time to review the proposal and respond. The proposal anticipates and seeks comments on a number of exceptions and exclusions from the FDA requirements.
The proposed rule would phase-out the current enforcement discretion approach by the FDA for LDT oversight. Once fully implemented in 2028 all in vitro diagnostics (IVDs) offered as LDTs by a laboratory would generally fall under the same enforcement approach as other IVDs. The current regulatory authority by FDA is based on a three-tiered system with quality management system, registration and listing, labeling, investigational device exemption, and adverse events medical device reporting requirements.
“The CAP requires additional time to evaluate the proposed rule, including the FDA arguments regarding oversight jurisdiction”, Dr. Volk said. “Going forward, we will continue to seek a balanced approach that allows patient access to safe and reliable diagnostic tests supported by a regulatory framework that is the least burdensome for laboratories.”