Laboratory developed tests regulation survey

The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) is concerned that the Food and Drug Administration’s (FDA’s) final rule to regulate laboratory developed tests (LDTs) will hinder the ability of healthcare institutions to deliver timely diagnoses and quality patient care. While the final rule carved out several exemptions that the agency claims will reduce the regulatory burden on laboratories, an ADLM survey of clinical labs shows that labs are still not equipped to meet the rule’s new requirements.

128 laboratories responded to the survey and overwhelmingly expressed concerns about their ability to perform LDTs under the FDA’s new rule. Key among these concerns is the fact that the FDA plans to impose documentation and other regulatory requirements on LDTs that the final rule exempts from the agency’s full review process. These exempt tests include so-called grandfathered tests that were offered prior to the publication of the rule, as well as tests that fill an unmet need that no FDA authorized test addresses. Among responding laboratories:

  • 73% said they lack the resources to comply with new documentation requirements for grandfathered LDTs.
  • 55% of these labs stated that the requirements will likely force them to discontinue some of these grandfathered LDTs.
  • 69% will also likely be forced to discontinue LDTs that fill an unmet need.

ADLM appreciates the intent of the final rule’s exemptions, but they are insufficient to alleviate the serious burden that the rule will impose on laboratories, which are already stringently regulated by the Centers for Medicare & Medicaid Services. The FDA’s regulatory framework is simply not appropriate for laboratory developed tests, and the results of ADLM’s survey demonstrate that placing these tests under dual FDA-CMS oversight will negatively impact patient care.

Laboratories’ ability to comply with new documentation requirements for grandfathered LDTs under the FDA’s final rule.

Figure 1: Laboratories’ ability to comply with new documentation requirements for grandfathered LDTs under the FDA’s final rule.

ADLM has sent a letter about the survey results to the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) and the House Committee on Energy and Commerce.

View the letter and full survey results here.

PAST SURVEY RESULTS

Prior to the publication of FDA’s final rule, ADLM conducted a survey that found that FDA regulation of laboratory developed tests would hinder pediatric care. Learn more.

ADLM will continue to update this page with the latest survey data.