FDA issues long-awaited LDT final rule

After years of trying, the US Food and Drug Administration (FDA) has released its plan to bring laboratory developed tests (LDTs) under its regulatory control over the next few years.

The much-anticipated final rule amends the agency’s regulations to treat in vitro diagnostic (IVD) tests made by laboratories as medical devices and offers a phased approach to their regulation. Under the final rule, FDA will provide a four-year phase-in period, during which it will gradually step up its requirements for LDTs, after which it expects most LDTs to be subject to the same regulatory approach as other IVDs.

The phase-in period will be in five stages:

• Stage 1 begins one year from the date of publication of the final rule. Test makers will be subject to the existing requirements for medical device reporting (MDR), corrections and removals, and quality system requirements for maintaining complaint files.
• Stage 2 begins two years from the publication date. The list of requirements for test makers to follow will expand to include requirements for establishment registration and device listing, labeling, and investigational use.
• Stage 3 begins three years from publication. Test makers will need to comply with the remaining quality system requirements under 21 CFR part 820 (QMSR).
• Stage 4 begins three and a half years from publication. Test makes will be expected to comply with premarket review requirements for high-risk IVDs offered as LDTs.
• Stage 5 begins four years from the final rule’s publication. Test makers will be expected to comply with premarket review requirements for low- and moderate-risk IVDs offered as LDTs for tests that would normally require premarket submissions.