FDA finalizes rules for laboratory developed tests

May 28, 2024

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Laboratory developed tests (LDTs) will finally be subject to government oversight in the United States under a new final rule released by the U.S. Food and Drug Administration (FDA) on April 29, 2024. The final rule will see the FDA amend its regulations so that in vitro diagnostic (IVDs) devices where the manufacturer is a laboratory are also considered devices under the Food, Drug, & Cosmetics (FD&C) Act.

Background and key takeaways

The FDA currently regulates IVDs under the FD&C Act but does not differentiate in its definition of device between entities manufacturing the device. As a result, since the Medical Device Amendments of 1976, the FDA has adopted a general enforcement discretion approach for LDTs and in most cases did not enforce applicable requirements for LDTs. In its final guidance, the FDA notes that recently LDTs “are used more widely, by a more diverse population, with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical healthcare decisions.”

The final rule outlines a four-year, five-step implementation for LDT regulation that will see a phased approach to when LDT sponsors must comply with different categories of FDA device regulations. The rule goes into effect on July 5, 2024 but the implementation states are tied to the rule’s official publication date of May 6, 2024. The five stages include:

  • Stage 1: LDTs will be subject to medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality systems requirements one year after the publication date.
  • Stage 2: LDTs must be in compliance with requirements not covered in other phases, including requirements for registration and listing, labeling, and investigational use two years after the publication date.
  • Stage 3: LDTs must comply with quality system requirements under 21 CFR part 820 three years after the publication date.
  • Stage 4: FDA will expect compliance with premarket review requirements for high-risk IVDs offered as LDTs, with a few exceptions, three and a half years after the publication date.
  • Stage 5: FDA will expect compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs, with a few exceptions, four years after the publication date.

Notably, LDTs that are already on the market will not be subject to the new final rule. The FDA also identified eight other types of LDTs that it will continue to approach with some level of enforcement discretion.

Looking ahead

Industry stakeholders, including the American Clinical Laboratory Association, have already expressed concerns with the final rule, cautioning that it may “limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics.” Legal experts are expecting litigation against the final rule, but for now stakeholders should move forward with preparing for the FDA to phase in its oversight of LDTs. Those who manufacture or sponsor LDTs should work with third-party experts to understand the regulatory environment and prepare for additional risks from FDA oversight and enforcement.

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Tags: Brand protection, Compliance, FDA, Legislation, Medical devices, Preserving brands, recall, regulations