FDA no longer releasing final guidance on laboratory developed tests

November 22, 2016

Alert

The U.S. Food and Drug Administration (FDA) announced last Friday that it will not release much anticipated final guidance on the regulation of laboratory developed tests (LDTs). Instead, the FDA indicated that it will continue to work with the new administration, Congress, and key stakeholders to determine the best approach to reform. It is unclear whether this means that the LDT regulatory approach proposed by the FDA is on hold or that the FDA is anticipating that the new administration will require a material change in approach.

The FDA stated that it believes patients and providers need accurate and reliable tests in order to make good health care decisions and that inaccurate test results can harm patients. The agency is seeking to develop a new LDT oversight policy that balances patient protection with continued access and innovation.

What is a LDT?

An LDT is defined by the FDA as an in vitro diagnostic test “that is intended for clinical use and designed, manufactured and used within a single laboratory.” The tests range from simple tests to complex genetic tests. LDTs are currently regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments. However, in 2014, the FDA published draft guidance stating that it would begin to regulate LDTs more like in vitro diagnostics. The FDA’s rationale for the change was that advances in technology and business models have enabled laboratories to develop more complex tests that reach patients nationwide. Several problems have been linked to complex LDTs, including claims insufficiently supported with evidence, lack of controls, and falsification of data. Before the 2014 draft guidance, the FDA sought to use existing classifications for medical devices to evaluate LDTs.

The future of LDTs

In response to the FDA’s attempts to regulate LDTs under the agency’s medical device authority, proponents of LDTs have pushed back and argued that LDTs are not medical devices and cannot be regulated as such. These entities applauded the FDA’s decision not to issue final guidance and have expressed their intent to work with the FDA, the new administration and other LDT stakeholders to reform LDT regulations going forward.

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FDA no longer releasing final guidance on laboratory developed tests

What is a LDT?

The future of LDTs

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