…Since its inception, the Coalition has worked closely with FDA to ensure that any new regulatory framework proposed by FDA for LDTs is reasonable, not overly burdensome, and acknowledges the differences between laboratory services and kits that are distributed to laboratories for performance. We appreciate the time and attention the agency has given to considering the Coalition’s views over the years, and in particular since releasing these latest draft guidances. The Coalition seeks to continue our efforts to work with the FDA toward the development of an appropriate regulatory model for advanced diagnostic tests that both protects public health and promotes innovation. It is critical that the Agency remains open to stakeholder views and adopts well-reasoned changes to the draft guidance that are both clear and not overly burdensome for laboratories.
Regulatory Position Statements
The Coalition for 21st Century Medicine’s Regulatory Workgroup engages with policy staff and senior leadership at the FDA, the congressional committees of jurisdiction, leading genomics patient groups, key academic leaders, and other stakeholders to advance a more appropriate regulatory framework for advanced diagnostic tests. The Coalition’s regulatory expertise has become a well known resource to both policymakers an legislators, with whom representatives of the Coalition Regulatory Committee routinely engage in smaller more focused issue meetings as well as in the context of larger and more public undertakings, such as submitting comments to the FDA on relevant policy issues, testifying before the U. S. House of Representatives, Committee on Energy & Commerce hearing regarding FDA regulation of laboratory developed tests, and presenting at the FDA public workshops and meetings. Additionally, the Coalition’s leadership hosted in-person meetings with the agency’s leadership, coordinated visits by FDA and CLIA officials and congressional leaders to member company clinical laboratories.
…Given the Coalition’s mission, we have a keen interest in the extent to which the U.S. Food and Drug Administration intends to regulate LDTs as medical devices as well as in the regulation of in vitro diagnostics more broadly.
The United States is at crossroads in the ongoing revolution of personalized medicine, and could fulfill the promise of “21st Century Cures” — early, rapid, and comprehensive diagnosis; and individualized, targeted treatments against serious and life-threatening diseases — only if regulators and public and private insurers align toward the objective.
Laboratory developed tests (LDTs) are currently subject to comprehensive regulations under the Clinical Laboratory Improvement Amendments (CLIA). The Food and Drug Administration (FDA) announced that it intends to regulate LDTs as medical devices and outlined the structure of a regulatory framework that the agency intends to implement once a Guidance Document is finalized.