FDA Delays Finalization of Lab-Developed Test Draft Guidance

Regulatory NewsRegulatory News
| 18 November 2016 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated.

Tara Goodin, press officer for FDA told Focus: "FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions."

Roger Klein, chair of the professional relations committee at the Association for Molecular Pathology, told Focus: "FDA's decision to delay release of a final LDT guidance is in the best interest of patients and providers, and supports further advancement in molecular pathology testing. We look forward to working with the FDA as we find ways to continue to improve the already high-quality testing that we provide to patients."

The American Clinical Laboratory Association also praised the move, with president Alen Mertz calling the decision “a victory for diagnostic innovation and most importantly, patients.”


LDTs have historically been regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, but in 2014, FDA issued draft guidance saying it would regulate LDTs more like in vitro diagnostics (IVDs).

"Initially, laboratories manufactured LDTs that were generally relatively simple, well-understood pathology tests or that diagnosed rare diseases and conditions that were intended to be used by physicians and pathologists within a single institution in which both were actively part of patient care," FDA explained in a 2010 meeting notice. "These tests were ordinarily either well-characterized, low-risk diagnostics or for rare diseases for which adequate validation would not be feasible and the tests were being used to serve the needs of the local patient population."

But in recent years, FDA has noticed LDTs becoming increasingly complex and in some cases nearly indistinguishable from their FDA-cleared devices. Of particular concern to FDA is that many LDTs play critical roles in clinical decision-making in the context of personalized medicine (e.g. genetic testing), which it said raises the risk of incorrect or missed diagnoses, resulting in untimely or improper treatment.

Last November, speaking at a House Energy & Commerce Committee hearing, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), defended the agency's plan to regulate LDTs, saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests."

Some members also argued against FDA increasing its oversight of LDTs. Rep. Michael Burgess (R-TX) said FDA's proposal would "stifle" innovation, saying it is "crucial that we do not slow innovation or create unnecessary regulatory hurdles … requiring premarket review by the FDA will impose new and arguably unnecessary requirements and costs on clinical laboratories, hospitals and doctors."

Other proposals have suggested dividing oversight of LDTs between FDA and CMS based on the type of test. Shuren rejected this approach, saying "such a system is going to lead to inefficiencies. It's going to lead to inconsistent standards treating the same test differently depending upon who makes the test … if we're going to assure that tests work we need one unified system."

And unlike traditional IVDs, LDTs are developed and used within a single laboratory. According to FDA, these tests historically were "relatively simple tests generally confined to local labs, and often used for rare conditions."

A draft bill floated ahead of that meeting also indicated what these regulations under FDA might look like moving forward.

The 185-page draft called for the creation of a new Center for In Vitro Clinical Tests within FDA, which would be tasked with classifying in vitro clinical tests as high-risk (if an inaccurate test result would cause serious harm, or death, to the patient), moderate-risk (if an inaccurate result for the intended use would cause non-life-threatening injury) and low-risk (meaning an inaccurate result would cause minimal or no harm, immediately reversible harm, or no patient disability).
The bill also sought to establish advisory panels to review and consider the classification of each LDT.


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