The Department of Health & Human Services announced that as part of regulatory flexibility related the COVID-19 public health emergency (PHE), the Food & Drug Administration (FDA is subagency of HHS) is rescinding all current guidances and informal issuances on Laboratory Developed Tests (LDTs) in favor of a formal notice-and-comment rulemaking or new legislation detailing FDA authority. HHS also announced that emergency use authorizations (EUAs) will no longer be required for LDTs to detect COVID-19 or antibodies to it.
In practice, this effectively ends FDA oversight of LDTs — an abrupt change from FDA’s recent push to regulate LDTs more closely. While the rescission impacts COVID-19 LDTs, it also appears to apply equally to other non-COVID LDTs, although HHS notes that testing manufacturers may still opt to seek premarket review. Additionally, should manufacturers fail to seek an EUA for a COVID-19 LDT test, that test will not be covered by the Public Readiness and Emergency Preparedness (PREP) Act immunity protections. Finally, HHS states that the rescissions will not affect existing EUAs or CMS oversight under the Clinical Laboratory Improvement Act (CLIA).
These changes to LDT oversight run counter to current ASHP policy on LDTs, which calls for more extensive FDA authority. ASHP policy 1412: FDA Oversight of Laboratory-Developed Tests advocates for “risk-based framework for regulatory oversight of laboratory-developed tests that promotes innovation while providing a mechanism to ensure that test results are reliable, reproducible, and clinically relevant.” FDA did not provide any details about potential frameworks for LDT oversight, but the agency will likely retain some authority over LDTs, such as regulating LDT components.
HHS did not provide a timeline for notice-and-comment rulemaking related to LDTs, nor did it suggest that this would be merely a temporary flexibility during the PHE. ASHP will update members as FDA and HHS provide additional information regarding LDT policy changes.