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FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests

Posted 20 April 2015 | By

FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests

The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies.


The move is related to FDA's efforts late last year to regulate LDTs more similarly to traditional medical devices, and in particular in vitro diagnostics (IVDS). FDA has long maintained its authority to regulate LDTs, which are tests developed by—and used within—a single institution.  Despite its claims of authority, FDA has largely ceded oversight of LDTs to CMS under the Clinical Laboratory Improvements Act (CLIA), under which all laboratory testing in the US is regulated.

In recent years, however, FDA has begun to express alarm that LDTs—once "well-characterized, low-risk diagnostics," in FDA's words—have become increasingly complex and in some cases nearly indistinguishable from FDA-approved or -cleared medical devices.

As a result, in August 2014 FDA announced its plans to issue a new draft guidance that would re-assert FDA's authority to regulate LDTs.

Read more on FDA's regulation of LDTs here.

FDA's proposal was immediately met with an outpouring of criticism by LDTs manufacturers, including the trade group representing them, the American Clinical Laboratory Association (ACLA), which has threatened to sue FDA over the proposal.

FDA, CMS Team Up

To date, it has been somewhat unclear how FDA's proposal would interact with CMS's authority under CLIA. FDA, for example, is authorized to regulate medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act), but is not authorized to regulate the practice of medicine. CMS, meanwhile, is not authorized to regulate medical devices, but is authorized to regulate some medical practices, including laboratory operations and testing processes.

But as FDA makes clear in a recent posting on its Voice blog, FDA's new approach to LDTs isn't intended to be an either/or proposal—both agencies plan to work closely together to regulate LDTs.

"When FDA’s proposed framework is implemented, both FDA and CMS will play a role in ensuring that LDTs are high quality—CMS through CLIA by continuing to focus on laboratory operations including the testing process and FDA by enforcing compliance with the agency’s quality systems regulation pertaining to the design and manufacture of the laboratory tests," FDA explained.

The two agencies say they are forming a task force on LDT quality requirements which will focus primarily on three areas:

  • identifying areas of similarity between the FDA quality system regulation and requirements under CLIA
  • working together to clarify responsibilities for laboratories that fall under the purview of both agencies
  • leveraging joint resources to avoid duplication and maximize efficiency

Another goal: simplifying regulatory approaches to make it easier for companies to bring LDTs to market and keep them compliant with regulations. "The task force understands stakeholders’ concerns about differences in terminology used by FDA and CMS," FDA wrote. "We intend to clarify the terms used so that labs may better understand what is expected of them."

FDA's taskforce is inviting feedback, which may be sent to


FDA Voice Blog


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