FDA proposes rule aimed at helping to ensure safety and effectiveness of laboratory developed tests
The U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure the safety and effectiveness of these tests, which are used in a growing number of healthcare decisions and for which concerns have been raised for many years.
The proposed rule seeks to amend the FDA’s regulations to make explicit that 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 policy under which the agency intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.
Under the approach described in the notice of proposed rulemaking, the FDA would phase out its general enforcement discretion approach for most LDTs. The proposed phaseout is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while avoiding undue disruption to the testing market. After this phaseout, the FDA generally would expect IVD makers to meet the same applicable requirements, except where meeting certain requirements under the Clinical Laboratory Improvement Amendments can be leveraged.
The FDA believes this proposal would also advance responsible innovation by both laboratory and non-laboratory IVD manufacturers alike by better assuring the safety and effectiveness of IVDs offered as LDTs and removing a disincentive for non-laboratory manufacturers to develop novel tests. The current approach disincentivizes innovation by non-laboratory manufacturers who meet FDA requirements and who compete with laboratory manufacturers who do not meet FDA requirements. Rectifying the current imbalance in oversight may foster innovation by manufacturers who are positioned to make safe and effective novel tests available to many labs.
In this proposed rule, the FDA also discusses alternative enforcement approaches for some IVDs offered as LDTs. To the extent commenters support or oppose these alternative approaches, the FDA is requesting a public health rationale, supporting evidence and other information to help inform FDA’s decision-making. Such different approaches include, among others: a different approach for academic medical center laboratories, the continuation of the current general enforcement discretion approach with respect to premarket review and quality system requirements for some or all currently marketed LDTs (i.e., what some previously referred to as “grandfathering”), a phaseout period tailored for small laboratories, and leveraging programs such as the New York State Department of Health Clinical Laboratory Evaluation Program or those within the Veterans Health Administration, as appropriate. Additionally, the FDA would facilitate increased use of the agency’s Third Party Review program.
