The FDA released a proposed rule on laboratory-developed test (LDT) regulation on September 29, 2023, seeking public comment until December 4, 2023. While the proposal is several dozen pages long, the proposed regulatory update can be easily summarized: The FDA considers LDTs to be medical devices and will regulate them in the same way as in vitro diagnostic (IVD) test kits. The FDA has proposed a four-year transition period for this change. The first three years of implementation include adverse event reporting, registration and listing, and quality management system requirements, with test submissions beginning at year 3.5 of the transition period.
Interested parties are encouraged to comment; the FDA recommends commenters support their suggestions or concerns with data and/or public health policy arguments. Though the FDA is required to respond to all comments, the agency is not required to accept or act on all remarks. Comments should ideally be informative and/or constructive; simply indicating approval or opposition to the proposed rule is unlikely to carry much weight.
In addition to general input on regulation of LDTs, the FDA is seeking input on several specific questions:
1. Should the agency consider grandfathering a subset of LDTs?
This concept would allow a subset of LDTs to remain on the market without needing to comply with certain medical device requirements, e.g., premarket review. It is likely that grandfathered LDTs would still need to comply with some medical device requirements, such as registration and listing, as directed by the FDA. A response to this question should include a description of tests that should be grandfathered and the justification for doing so.
2. Should small laboratories have a longer transition period?
The rationale is presumably that smaller clinical laboratories will have fewer resources to comply with medical device requirements. A response to this question should include a proposed definition of a “small laboratory,” supporting information to justify delayed implementation for such laboratories, and a proposed expanded timeline.
3. Should academic medical centers be excluded from certain medical device requirements?
A response to this question should include a proposed definition of an academic medical centers (AMC) and a description of the medical device requirements that AMCs should be exempt from, e.g., premarket review, quality system requirements, etc.
4. Should the FDA utilize existing premarket review programs such as the New York State Clinical Laboratory Evaluation Program as a surrogate for FDA premarket review?
Such an approach would be conceptually similar to the FDA’s existing third-party review program. A response to this question should include the characteristics and activities an eligible third-party reviewer should demonstrate and any limitations that should be placed on such an entity, e.g., limiting their review to low or moderate risk LDTs.
Though FDA regulation of LDTs is not a new topic, the release of this proposed rule is a significant step in the LDT saga. Clinical laboratories should strongly consider submitting comments before December 4.