FDA Will Not Release Final LDT Guidance

The FDA has announced that it will not release final guidance on laboratory developed tests (LDTs), and instead will work with Congress and other stakeholders to determine how LDTs should be regulated, the American Clinical Laboratory Association (ACLA) said.

The decision “is a victory for diagnostic innovation and most importantly, patients,” Alan Mertz, the ACLA’s president, said. “We appreciate the FDA’s acknowledgement that stakeholder input and the ongoing bipartisan work carried out in the House and Senate is the appropriate process to advance comprehensive statutory reform of the LDT regulatory framework.”

Mertz said the ACLA has consistently maintained that LDTs are not medical devices and cannot be regulated as such.

The FDA proposed draft guidance in October 2014 for the agency to begin regulating LDTs using a risk-based framework (IDDM, Oct. 3).

But, senators said during a recent committee hearing that the FDA does not have the capacity to regulate the tens of thousands of LDTs currently being used across the country, (IDDM, Sept. 23).

Currently, most tests that are developed and used within a single facility are regulated by the Centers for Medicare & Medicaid Services, under the Clinical Laboratory Improvement Amendments. They can include in vitro diagnostics, blood tests, and assays evaluating whether a patient will respond to a specific drug.