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How Should FDA Regulate Lab-Developed Tests? Agency Wants to Know

Posted 25 November 2014 | By Alexander Gaffney, RAC

How Should FDA Regulate Lab-Developed Tests? Agency Wants to Know

The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices.


Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to the Clinical Laboratory Improvement Amendments (CLIA), a law intended to ensure laboratories and the testing conducted therein are held to acceptable standards.

In recent years, however, FDA regulators have expressed their view that LDTs have in some cases become complex enough to make them indistinguishable from FDA-approved or -cleared devices. Of particular concern to FDA is that some of the LDTs, such as genomic sequencing tests, are used to support or enhance clinical decision-making without having undergone a rigorous review of their efficacy or accuracy.

After years of indicating it intended to regulate LDTs more like in vitro diagnostic testing products, in August 2014 FDA announced the release of a new draft guidance that would reverse what it called its “enforcement discretion” allowing LDTs to be regulated under CLIA. Under the new regulatory paradigm, FDA would subject some LDTs—high-risk LDTs, in particular—to registration, listing, adverse event reporting and premarket review requirements.

While traditional medical device manufacturers greeted FDA’s LDT proposal favorably, LDT manufacturers (and some legislators) greeted it with scorn and threats. The policy, the latter said, would act as a deterrent to developing new innovative products capable of helping consumers. FDA's policy also violated the law, LDT groups alleged, and ought to have been promulgated as a proposed regulation—not a guidance. The group has also retained two extremely prominent attorneys, Paul Clement and Laurence Tribe, to represent their interests in the event that FDA's draft guidance is finalized.

                For an extensive explanation of FDA’s proposed LDT policy, please read our explanation here.

Public Comment

Now LDT groups, medical device manufacturers and the public will get a chance to weigh in on FDA's LDT proposal.

In a Federal Register announcement on 24 November 2014, FDA said it plans to hold a workshop on its LDT oversight framework. The notice—unusually thorough compared to most FDA announcements—provides a defensive overview of FDA's rationale for changing its LDT enforcement policy.

FDA said it intends to use the forum to allow the public to weigh in on five specific issues related to its LDT framework:

  1. factors for “Traditional LDT” and appropriate level of enforcement discretion for such tests
  2. factors for considering LDTs for rare diseases
  3. manufacture and use of LDTs solely within a healthcare system as a risk mitigation supporting some continued enforcement discretion
  4. timeframe for phase-in enforcement of QS regulation requirements for those LDTs called in for enforcement of premarket review requirements early in the implementation period
  5. the appropriateness of a single notification for the same LDT manufactured by multiple labs owned by a single entity

 The overarching goal, FDA said, is to figure out "how to best balance patient safety and patient access in developing the finalized framework in a manner that best serves public health."



Federal Register Notice

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