In August 2014, the U.S. Food and Drug Administration (FDA) announced that within 60 days it would publish a draft guidance on the regulation of laboratory-developed tests (LDTs, or LDPs for “laboratory-developed procedures”), and indeed, in October 2014 it did just that, in the form of two documents: “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).” Laboratorians, and the organizations that represent them—including the American Clinical Laboratory Association (ACLA), the American Association for Clinical Chemistry (AACC), and the Association for Molecular Pathology (AMP), among others—did not like what they read, and promptly vowed to oppose changes that would interfere with clinical labs’ ability to serve patients.
What was in the draft guidance? There were several important points:
- The FDA drew a distinction between “traditional” LDTs—those developed by a lab for its own patient population—and nontraditional LDTs, the kind that are developed by commercial ventures, which have increased greatly in recent years, in part due to molecular diagnostics.
- Regulation of the former would involve reporting on the performance of the tests, and of adverse events, to the FDA. They would essentially continue to be regulated by CLIA ’88.
- The agency’s treatment of the nontraditional LDTs would be very different, however. They would be classified as moderate- or high-risk, and labs would be subject to much more onerous regulation.
- The development of new LDTs would have to follow the customary FDA premarket process for determining level of risk…
- …Because the FDA would consider them “medical devices” like any other such devices that come under its purview.
That last bullet was the red flag for many lab organizations that took up arms against the draft guidance. The whole idea of the agency applying regulations intended for medical device manufacturers to LDT creators could cast a chilling effect on LDT development. True, LDTs may no longer be the classic “home brew” assays they were years ago, but they aren’t medical devices either.
Wrote Alan Mertz, president of the ACLA in these pages in the November 2014 issue: “LDTs are not ‘devices’ as defined by the Food, Drug, and Cosmetic Act. As the text and legislative history of the ‘device’ definition show, the term encompasses only articles. LDTs are proprietary procedures for performing a diagnostic test using reagents and laboratory equipment. They are essentially know-how, not physical articles.”
And, in any case, aren’t they already regulated under CLIA? Some organizations have championed the idea of updating CLIA to accommodate what all acknowledge is the changing nature of LDTs and to enhance patient safety—but not to duplicate regulation, or make it unfairly onerous, by involving the FDA.
To its credit, the FDA listened to all interested parties during the 120-day comment period that began after the release of the draft guidance. It considered a recommendation from a coalition of some 50 healthcare-related organizations asking that the guidelines be withdrawn and that LDTs be regulated instead via a notice and comment rulemaking process (that would trigger an economic impact study). The FDA announced in May 2015 that an interagency taskforce was being formed, comprised of the FDA, the Centers for Medicare and Medicaid Services (CMS), and other stakeholders. The agency has moved with deliberate speed. In fact, there has been something of a feeling among lab leaders of waiting for the other shoe to drop.
Which brings us to the good news—good for now, anyway: In November, the FDA announced that it is backing off on its plan to issue final guidance for LDTs or LDPs. “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,” the agency said. Stay tuned.
