LDTs now fall under relaxed FDA regulations with rescission of HHS guidances.
The US Department of Health and Human Services (HHS) published a notice Aug. 19, 2020, addressing the regulation of laboratory-developed tests (LDTs). This new guidance indicates that the US Food and Drug Administration (FDA) does not have the authority to regulate LDTs, and the LDTs will not require any FDA premarket review.
The notice by the HHS states, “The department has determined that the FDA will not require premarket review of LDT absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.”
While not required, HHS further said, “Those seeking approval or clearance of, or an emergency use authorization (“EUA”) for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions.”
HHS also provided criteria that those using LDTs must still consider: “Those opting to use LDTs in their laboratories without FDA premarket review or authorization may do so with the understanding that they would not be eligible for PREP Act coverage absent approval, clearance or authorization and would remain subject to regulation by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988, and its implementing regulations.”
Clinical laboratory leaders who wish to review the full text of the HHS notice can view it here.
Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests