FDA, CMS Form Task Force To Coordinate LDT Regulation

April 17, 2015

The Centers for Medicare & Medicaid Services and U.S. FDA are establishing an interagency task force to address issues around the regulation of laboratory-developed tests, including LDT quality requirements.

Leaders and subject matter experts from both agencies will identify areas of overlap and work to clarify responsibilities, minimize duplication and maximize efficiency, the FDA and CMS said Thursday. The task force will also clarify terminology each agency uses to ensure that laboratories understand what is expected of them and offer stakeholder education, including an upcoming webinar series on LDTs.

The FDA proposed a risk-based regulatory framework for LDTs in October that establishes registration, approval and reporting requirements for the tests. The agency is currently reviewing comments from stakeholders and could modify its final guidance to reflect concerns about the draft (IDDM, Feb. 6).

Once the FDA framework takes effect, the agency will be responsible for LDTs themselves, but CMS will retain oversight of the laboratories under the provisions of the Clinical Laboratory Improvement Act. This includes overseeing laboratory operations and qualifications of laboratory staff.

The group will have about 20 members and plans to meet for “many months,” says FDA spokeswoman Jennifer Dooren.

AdvaMed called the task force a positive step. Stakeholders have been confused as to how the two agencies will divvy up responsibilities related to LDT oversight. Historically, CMS has regulated LDTs via its CLIA authority, but FDA has said growing use and increasing complexity of these tests warrants stricter regulation.

Stakeholders who have thoughts about the task force should contact the FDA at LDTFramework@FDA.hhs.gov. — Elizabeth Orr