The deadline to comment on a U.S. Food & Drug Administration (FDA) proposed rule to begin regulating Laboratory Developed Tests (LDTs) is December 4. ASCLS encourages all members of our community to read the proposal and provide input.
The proposed rule would amend the FDA’s regulations to make explicit that LDTs (defined by FDA as in vitro diagnostic products (IVDs)) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a phaseout of its “general enforcement discretion approach to LDTs” that has been in place in place since the 1970s.
The ASCLS Government Affairs Committee and the ASCLS Board of Directors are reviewing the proposed rule and will provide comments. ASCLS currently has no position on this proposed rule but will share the Society’s written comments in the ASCLS Open Forum when complete. ASCLS has been a supporter of the most recent iteration of the VALID Act in Congress, which would create a more modern framework for regulation of LDTs. ASCLS been in favor of some regulation of LDTs as long as that regulation is narrowly focused and risk-based. It is yet unclear if this proposed rule meets those criteria, but the Society is concerned that, as written, the change would negatively impact the clinical laboratories community to continue to provide the same level of testing for patients.
The rule is very detailed in the legislative and regulatory history of this issue and enumerates areas where the FDA will continue to apply “enforcement discretion” (i.e., will not regulate). There are a number of examples FDA provides, but in particular the following: “FDA is proposing to continue to apply the current general enforcement discretion approach going forward. One such category of tests is referred to in this preamble as ‘1976-Type LDTs.’ Such tests have the following characteristics common among LDTs offered in 1976: use of manual techniques (without automation) performed by laboratory personnel with specialized expertise; use of components legally marketed for clinical use; and design, manufacture, and use within a single CLIA-certified laboratory that meets the requirements under CLIA for high complexity testing.”
It is clear that FDA intends to publish a final rule (which has the effect of making it federal law) no later than summer of 2024. It appears, though, that the final form of that rule may change substantially based on feedback from the clinical laboratory community.
All laboratory professionals that have LDTs in their laboratories should provide comments to the FDA, providing specifics around their tests, their impact on patients care, and the negative effects should an overly broad rule be put in place. FDA needs to be aware of the full scope of how broadly LDTs are used and the variety of approaches.